Postoperative PainPhase 3NCT00814580
Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery
A Phase 3 study testing Tapentadol IR and Oxycodone IR in people with Postoperative Pain, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
Trial summary
The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Tapentadol IR and Oxycodone IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Mar 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy on the basis of medical history and vital signs and meeting the American Society of Anesthesiology (ASA) physical status I, II, or III
- completed screening procedures and have undergone one of the following elective outpatient arthroscopic surgical procedures: rotator cuff repair, labral tear repair, Bankart repair
- an arthroscopic mini-open rotator cuff repair
- (an arthroscopic distal clavicle resection performed in conjunction with a rotator cuff, labral tear or Bankart repair is also permitted)
- received anesthesia administered to the shoulder by interscalene nerve block
- receive study medication as the first oral analgesic medication following the orthopedic surgical procedure and expected to have moderate to severe pain requiring oral opioids for at least 3 days after surgery.
Who cannot join
- Patients whose post-operative pain would require non opioid analgesia as standard of care
- received a non-allowed procedure
- received intraoperative or post-operative anesthesia and/or analgesic medications which are expected to provide post-operative analgesia for >24 hours after discharge from the PACU (recovery room)
- received intraoperatively >200 mg fentanyl or the morphine equivalent of another opioid (for the total procedure) or potent inhaled anesthesia (e.g., sevoflurane, isoflurane)
- received IV PCA analgesia (intravenous pump the patient controls) in the PACU or a PACU stay >8 hours
- expected to require inpatient treatment in a hospital or rehabilitation unit post operatively
Show all 27Show fewer
- anticipate any surgical procedure(s) within 7 days after the initial shoulder surgery
- have significant nausea and/or vomiting at the time of randomization (patients may receive an anti-emetic prior to or during surgery)
- received any of the following: long-acting or controlled-release opioids within 1-month prior to randomization
- immediate release CII opioid formulations (e.g., Opana IR, Percocet, Percodan, oxycodone IR, Dilaudid) for >5 days total within 1 month before, and within 24 hours of, randomization
- intra-articular (within a joint) or systemic steroids (except inhalers and topical steroids), within 1 month before randomization (exception, patients on a stable dose of chronic steroids for a minimum of 3 months, for a condition other than the shoulder pain)
- use of non-steroidal anti-inflammatory drugs (NSAIDs) within 24-hours of randomization
- have taken any CIII opioid formulation (e.g., Tylenol with Codeine) >3 days/week in the 1-month prior to randomization
- treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitors (SNRIs) within 2 weeks before randomization
- positive urine drug screen (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, barbiturates, and oxycodone)
- have an active systemic or local infection
- significant co-existing autoimmune inflammatory conditions
- history of seizure disorder or epilepsy
- presence of any of the following: mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
- severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, or post-traumatic amnesia of more than 24 hours duration within 15 years of screening
- known history of alcohol or drug abuse in the study doctor's judgment based on medical history
- known or suspected to be opioid tolerant or dependent
- known history of laboratory values reflecting severe kidney disease, known history of moderately or severely impaired liver function
- history of allergy to, or hypersensitivity to tapentadol, oxycodone, or other components of the medication
- history (within the past 6 months) of a major psychiatric disorder
- history of suicidal ideation or suicidal attempts within the past 2 years
- currently involved in litigation regarding their shoulder injury, have a disability claim or patients who are receiving Worker's Compensation due to their shoulder injury or are being evaluated to receive disability or Worker's Compensation
About this study
Official title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study of Tapentadol Immediate Release (IR) Versus Oxycodone IR for the Treatment of Subjects With Acute Post-Operative Pain Following Elective Arthroscopic Shoulder Surgery
The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
Read the detailed description
This is a double-blind (neither the patient nor the study doctor knows the name of the assigned study drug during the study), randomized (study drug selected by chance like flipping a coin), active-comparator (patient will get active drug and there is no inactive drug), outpatient study to evaluate efficacy and how well a patient tolerates multiple doses of tapentadol immediate release (IR) versus oxycodone IR for short-term moderate to severe post-operative pain after arthroscopic (a surgical technique whereby a doctor inserts a tube-like instrument into a joint to visually inspect and repair tissues) shoulder surgery. About 370 patients will be enrolled to either receive tapentadol IR or oxycodone IR until approximately 150 patients in each treatment group are enrolled. After obtaining informed consent, patients will have screening visit procedures to determine study eligibility. Visit 1 (screening) may begin up to 21 days prior to surgery. Pre-operative assessments (e.g., physical examinations, clinical laboratory assessments) will be conducted as part of routine procedures. Patients will have a urine drug test and women who are able to have children will have a urine pregnancy test performed as part of screening prior to the study. Height and weight will be taken and a sleep questionnaire will also be completed at screening. Study staff will conduct pre-operative teaching regarding post-operative pain including: the pain intensity assessment for the study (11-point numeric rating scale where 0=no pain and 10=pain as bad as you can imagine); descriptions of mild, moderate and severe pain; instructions for dosing with study medication; and completing the study diary. Eligible patients will be post-operative men and women who have undergone elective outpatient arthroscopic shoulder surgery. Patients must have received a regional interscalene (within the scalene muscles) nerve block as the primary anesthetic (numbing medication) during the procedure and do not require intravenous (through a vein) patient-controlled analgesia post-operatively. Patients who are expected to have moderate to severe acute post-operative pain from shoulder surgery and who are appropriate candidates for outpatient pain management with an oral opioid (narcotic) pain medication will be eligible. In addition, appropriate patients are expected to require oral opioid pain medication post-operatively. Patients who continue to meet all study criteria post-operatively will be assigned to a study drug group prior to PACU discharge (PACU is considered Visit 2) and will be sent home with study medication. All patients will be prescribed a standard regimen of cold pack application to the surgical shoulder. Patients will be instructed to take the first dose of study medication as their first oral pain medication when they have at least "moderate" pain (prior to discharge or at home). Patients will be reminded about instructions on post-operative pain that were discussed during the pre-operative screening visit. Patients will also be instructed to complete a diary assessment of their current pain intensity before taking the first dose of study medication. Day 1 will be the calendar day when the patient takes the first dose of study medication. Starting on Day 1, patients will be instructed to complete assessments in paper diaries each morning and evening related to pain intensity, pain relief, and occurrences of vomiting. All patients will be contacted by telephone by a member of the study staff on the day following surgery. The staff will verify that the first dose of study medication was taken and the baseline pain intensity assessment was recorded. All patients will receive a second telephone call from the study staff on Day 3. During this telephone call, site personnel will inquire about the patient's overall status and will reinforce diary compliance. If the study staff determines it is necessary, the patient will be required to return to the study site for an unscheduled visit. Patients may take up to 2 pills (any form) of acetaminophen for pain other than post-operative shoulder pain (e.g., headache, back pain) once per day only for up to a total of 2 days during the study. Patients who take up to 325 mg/day aspirin as prevention for a heart condition will be permitted to enter the study and continue on study medication provided they are on a stable dose for at least 1 month prior to study entry and plan to continue the same dose during the study. Patients who complete the study will return to the study site for a final visit (Visit 3) on Day 7. Patients who discontinue early for any reason (i.e., lack of efficacy, adverse events, patient's choice) should contact the study staff before taking supplemental pain medication and schedule his/her final visit. Patients will complete a final assessment of pain intensity and pain relief. In addition, all patients will complete a sleep questionnaire, a Patient Global Impression of Change and an assessment of satisfaction with treatment. The study doctor will complete a Clinician Global Impression of Change and will record any medical resource utilization noted in the office charts (e.g., unplanned calls from the subject, unscheduled office visits, emergency room visits). Vital signs will be obtained and study medication will be collected and counted. Patients will have adverse events assessed and any changes in concomitant medications (other medications taken at the same time as the study medication) recorded. All patients will have post-study medication prescribed at the study doctor's discretion. A patient may elect to take supplemental pain medication to treat their post-operative shoulder pain at any time during the study; however, patients who take supplemental pain medication will be considered discontinued from the study. Patients will be assigned by chance equally (1:1) in a blinded (neither the patient or study doctor knows) fashion to get tapentadol immediate release (IR) 50 or 100 mg vs oxycodone IR 5 or 10 mg, every 4-6 hours as needed. Treatment is up to 7 days starting on Day 1 with one capsule of study medication. A "re-dose" is permitted and may be administered as soon as one hour after the first dose only. For subsequent doses, patients may take one or two capsules every 4 to 6 hours as needed.
- Conditions
- Postoperative Pain
- Being tested
- Tapentadol IR, Oxycodone IR
- Keywords
- analgesia, postoperative pain, opioid, rotator cuff repair, labral tear repair, Bankart procedure, oxycodone, tapentadol, arthroscopic shoulder surgery
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol IRDrug
First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed
Oxycodone IRDrug
First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Tapentadol IR First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1 if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed Receives: Drug: Tapentadol IR |
| 002 | Active comparator | Oxycodone IR First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1 if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed Receives: Drug: Oxycodone IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.
Measured: 3 Days (72 hours)
Secondary outcomes (33)
Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline
From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.
Measured: 7 Days
Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline
From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.
Measured: 7 Days
Summary of 30% Responder Rate (With Imputation) on Day 3
The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward.
Measured: Day 3
Summary of 30% Responder Rate (With Imputation) on Day 7
The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Measured: Day 7
Summary of 50% Responder Rate (With Imputation) on Day 3
The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Measured: Day 3
Summary of 50% Responder Rate (With Imputation) on Day 7
The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Measured: Day 7
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.
Measured: 2 Days (48 hours)
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief.
Measured: 7 Days
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.
Measured: 2 Days (48 hours)
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.
Measured: 3 Days (72hours)
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief.
Measured: 7 Days
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.
Measured: 2 Days (48 hours)
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.
Measured: 3 Days (72hours)
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief.
Measured: 7 Days
Subject Satisfaction With Treatment
Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied
Measured: 7 Days
Patient Global Impression of Change (PGIC) at End of Study
Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
Measured: 7 Days
Clinician Global Impression of Change (CGIC) at End of Study
Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
Measured: 7 Days
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.
Measured: 7 Days
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.
Measured: 7 Days
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Over the past 7 days patients reported "trouble falling asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Over the past 7 days patients reported "trouble falling asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Over the past 7 days patients reported "Wake up several times during night" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Over the past 7 days patients reported "Wake up several times during night" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Over the past 7 days patients reported "Trouble staying asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Over the past 7 days patients reported "Trouble staying asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Over the past 7 days patients reported "Pain interferes with sleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Over the past 7 days patients reported "Pain interferes with sleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Over the past 7 days patients reported "Wake up feeling tired and worn out" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Over the past 7 days patients reported "Wake up feeling tired and worn out" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Over the past 7 days patients reported "Feeling alert during daytime hours" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Over the past 7 days patients reported "Feeling alert during daytime hours" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Over the past 7 days patients reported "Feeling well rested" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Over the past 7 days patients reported "Feeling well rested" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Measured: Baseline and 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814580
- Sponsor's protocol ID
- CR015040
- Other IDs
- R331333PAI3022, KF5503/49
- Status last verified
- Nov 2012
- First submitted
- 23 Dec 2008
- Last updated
- 20 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vorsanger GJ, Klopfer AM, Xiang J, Benson CJ, Moskovitz BL, Rosenthal NR. Immediate-release tapentadol or oxycodone for treatment of acute postoperative pain after elective arthroscopic shoulder surgery: a randomized, phase IIIb study. J Opioid Manag. 2013 Jul-Aug;9(4):281-90. doi: 10.5055/jom.2013.0170.
PubMed 24353022
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multi-Center, Parallel-Group Study of Tapentadol Immediate Release (IR) Versus Oxycodone IR for the Treatment of Subjects With Acute Post-Operative Pain Following Elective Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT00814580
- Acronym / sponsor ID
- CR015040
- Conditions
- Postoperative Pain
- Keywords
- analgesia, postoperative pain, opioid, rotator cuff repair, labral tear repair, Bankart procedure, oxycodone, tapentadol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Dec 2008 (estimated)
- Results
- Posted 10 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
Detailed description
This is a double-blind (neither the patient nor the study doctor knows the name of the assigned study drug during the study), randomized (study drug selected by chance like flipping a coin), active-comparator (patient will get active drug and there is no inactive drug), outpatient study to evaluate efficacy and how well a patient tolerates multiple doses of tapentadol immediate release (IR) versus oxycodone IR for short-term moderate to severe post-operative pain after arthroscopic (a surgical technique whereby a doctor inserts a tube-like instrument into a joint to visually inspect and repair tissues) shoulder surgery. About 370 patients will be enrolled to either receive tapentadol IR or oxycodone IR until approximately 150 patients in each treatment group are enrolled. After obtaining informed consent, patients will have screening visit procedures to determine study eligibility. Visit 1 (screening) may begin up to 21 days prior to surgery. Pre-operative assessments (e.g., physical examinations, clinical laboratory assessments) will be conducted as part of routine procedures. Patients will have a urine drug test and women who are able to have children will have a urine pregnancy test performed as part of screening prior to the study. Height and weight will be taken and a sleep questionnaire will also be completed at screening. Study staff will conduct pre-operative teaching regarding post-operative pain including: the pain intensity assessment for the study (11-point numeric rating scale where 0=no pain and 10=pain as bad as you can imagine); descriptions of mild, moderate and severe pain; instructions for dosing with study medication; and completing the study diary. Eligible patients will be post-operative men and women who have undergone elective outpatient arthroscopic shoulder surgery. Patients must have received a regional interscalene (within the scalene muscles) nerve block as the primary anesthetic (numbing medication) during the procedure and do not require intravenous (through a vein) patient-controlled analgesia post-operatively. Patients who are expected to have moderate to severe acute post-operative pain from shoulder surgery and who are appropriate candidates for outpatient pain management with an oral opioid (narcotic) pain medication will be eligible. In addition, appropriate patients are expected to require oral opioid pain medication post-operatively. Patients who continue to meet all study criteria post-operatively will be assigned to a study drug group prior to PACU discharge (PACU is considered Visit 2) and will be sent home with study medication. All patients will be prescribed a standard regimen of cold pack application to the surgical shoulder. Patients will be instructed to take the first dose of study medication as their first oral pain medication when they have at least "moderate" pain (prior to discharge or at home). Patients will be reminded about instructions on post-operative pain that were discussed during the pre-operative screening visit. Patients will also be instructed to complete a diary assessment of their current pain intensity before taking the first dose of study medication. Day 1 will be the calendar day when the patient takes the first dose of study medication. Starting on Day 1, patients will be instructed to complete assessments in paper diaries each morning and evening related to pain intensity, pain relief, and occurrences of vomiting. All patients will be contacted by telephone by a member of the study staff on the day following surgery. The staff will verify that the first dose of study medication was taken and the baseline pain intensity assessment was recorded. All patients will receive a second telephone call from the study staff on Day 3. During this telephone call, site personnel will inquire about the patient's overall status and will reinforce diary compliance. If the study staff determines it is necessary, the patient will be required to return to the study site for an unscheduled visit. Patients may take up to 2 pills (any form) of acetaminophen for pain other than post-operative shoulder pain (e.g., headache, back pain) once per day only for up to a total of 2 days during the study. Patients who take up to 325 mg/day aspirin as prevention for a heart condition will be permitted to enter the study and continue on study medication provided they are on a stable dose for at least 1 month prior to study entry and plan to continue the same dose during the study. Patients who complete the study will return to the study site for a final visit (Visit 3) on Day 7. Patients who discontinue early for any reason (i.e., lack of efficacy, adverse events, patient's choice) should contact the study staff before taking supplemental pain medication and schedule his/her final visit. Patients will complete a final assessment of pain intensity and pain relief. In addition, all patients will complete a sleep questionnaire, a Patient Global Impression of Change and an assessment of satisfaction with treatment. The study doctor will complete a Clinician Global Impression of Change and will record any medical resource utilization noted in the office charts (e.g., unplanned calls from the subject, unscheduled office visits, emergency room visits). Vital signs will be obtained and study medication will be collected and counted. Patients will have adverse events assessed and any changes in concomitant medications (other medications taken at the same time as the study medication) recorded. All patients will have post-study medication prescribed at the study doctor's discretion. A patient may elect to take supplemental pain medication to treat their post-operative shoulder pain at any time during the study; however, patients who take supplemental pain medication will be considered discontinued from the study. Patients will be assigned by chance equally (1:1) in a blinded (neither the patient or study doctor knows) fashion to get tapentadol immediate release (IR) 50 or 100 mg vs oxycodone IR 5 or 10 mg, every 4-6 hours as needed. Treatment is up to 7 days starting on Day 1 with one capsule of study medication. A "re-dose" is permitted and may be administered as soon as one hour after the first dose only. For subsequent doses, patients may take one or two capsules every 4 to 6 hours as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Tapentadol IRTapentadol IR First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1 if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed |
| 002 | Active comparator | Drug: Oxycodone IROxycodone IR First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1 if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy on the basis of medical history and vital signs and meeting the American Society of Anesthesiology (ASA) physical status I, II, or III
- completed screening procedures and have undergone one of the following elective outpatient arthroscopic surgical procedures: rotator cuff repair, labral tear repair, Bankart repair
- an arthroscopic mini-open rotator cuff repair
- (an arthroscopic distal clavicle resection performed in conjunction with a rotator cuff, labral tear or Bankart repair is also permitted)
- received anesthesia administered to the shoulder by interscalene nerve block
Key exclusion criteria (27 listed)
- Patients whose post-operative pain would require non opioid analgesia as standard of care
- received a non-allowed procedure
- received intraoperative or post-operative anesthesia and/or analgesic medications which are expected to provide post-operative analgesia for >24 hours after discharge from the PACU (recovery room)
- received intraoperatively >200 mg fentanyl or the morphine equivalent of another opioid (for the total procedure) or potent inhaled anesthesia (e.g., sevoflurane, isoflurane)
- received IV PCA analgesia (intravenous pump the patient controls) in the PACU or a PACU stay >8 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapentadol IRFirst dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed | Drug | 001 |
| Oxycodone IRFirst dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed | Drug | 002 |
Primary outcome
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)
Time frame: 3 Days (72 hours)
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.
33 secondary outcomes
Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline
Time frame: 7 Days
Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline
Time frame: 7 Days
Summary of 30% Responder Rate (With Imputation) on Day 3
Time frame: Day 3
Summary of 30% Responder Rate (With Imputation) on Day 7
Time frame: Day 7
Summary of 50% Responder Rate (With Imputation) on Day 3
Time frame: Day 3
Summary of 50% Responder Rate (With Imputation) on Day 7
Time frame: Day 7
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)
Time frame: 2 Days (48 hours)
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days
Time frame: 7 Days
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)
Time frame: 2 Days (48 hours)
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)
Time frame: 3 Days (72hours)
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days
Time frame: 7 Days
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)
Time frame: 2 Days (48 hours)
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)
Time frame: 3 Days (72hours)
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days
Time frame: 7 Days
Subject Satisfaction With Treatment
Time frame: 7 Days
Patient Global Impression of Change (PGIC) at End of Study
Time frame: 7 Days
Clinician Global Impression of Change (CGIC) at End of Study
Time frame: 7 Days
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Time frame: 7 Days
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Time frame: 7 Days
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time frame: Baseline and 7 Days
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time frame: Baseline and 7 Days
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time frame: Baseline and 7 Days
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time frame: Baseline and 7 Days
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time frame: Baseline and 7 Days
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time frame: Baseline and 7 Days
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time frame: Baseline and 7 Days
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time frame: Baseline and 7 Days
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time frame: Baseline and 7 Days
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time frame: Baseline and 7 Days
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time frame: Baseline and 7 Days
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time frame: Baseline and 7 Days
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time frame: Baseline and 7 Days
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time frame: Baseline and 7 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24353022Vorsanger GJ, Klopfer AM, Xiang J, Benson CJ, Moskovitz BL, Rosenthal NR. Immediate-release tapentadol or oxycodone for treatment of acute postoperative pain after elective arthroscopic shoulder surgery: a randomized, phase IIIb study. J Opioid Manag. 2013 Jul-Aug;9(4):281-90. doi: 10.5055/jom.2013.0170.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tapentadol IR and Oxycodone IR in people with Postoperative Pain, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours) (time frame: 3 Days (72 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00814580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.