PainPhase 4NCT01631513
An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)
A Phase 4 study testing Nucynta ER in people with Pain and Chronic Back Pain, run by Janssen Scientific Affairs, LLC at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate tapentadol Extended Release (ER) in the treatment of moderate to severe chronic pain in participants with a diagnosis of chronic low back pain (LBP) or osteoarthritis (OA) of the hip or knee after conversion from hydrocodone, oxycodone Controlled Release (CR), and/or morphine… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Pain, Chronic Back Pain, Chronic Low Back Pain
- What is being tested?
- Nucynta ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a clinical diagnosis of knee or hip osteoarthritis (OA) with history of pain at the reference joint or clinical diagnosis of low back pain (LBP) of non malignant origin for at least 3 months before the screening visit; Be taking hydrocodone, oxycodone CR, or morphine SR for the treatment of chronic LBP, or OA of the knee or hip for at least 2 weeks before the screening visit; Have a baseline pain intensity score of ≥4 on an 11-point pain intensity numeric rating scale; Be willing and able to independently communicate pain characteristics, complete all protocol required measurements/assessments without assistance, understand and complete self-administered questionnaires and adhere to the prohibitions and restrictions specified in this protocol.
Who cannot join
- Had surgery in the low back area or the reference joint within 3 months before the screening visit, or will not have fully recovered from surgery by the screening visit, or is expected to require surgical intervention in the low back area or the reference joint during participation in the study; For participants with OA of the hip or knee, has a clinical history and findings at the reference joint suggesting the pain is secondary to crystal-induced, metabolic, infectious, and/or autoimmune disease(s); Has a known history of severe chronic renal insufficiency, severely impaired hepatic function, or alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal; Has a history of seizure disorder, epilepsy, or recurrent seizures; Has any of the following within 1 year before the screening visit: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm; Has a known or suspected history of alcohol abuse in the past 10 years or any history of drug abuse; Has a history of malignancy within 2 years before the screening visit, with the exception of basal cell carcinoma that has been successfully treated; Has significant respiratory depression, acute or severe bronchial asthma, or hypercapnia and paralytic ileus; Has a known history of allergies, hypersensitivity, or contraindication to tapentadol, hydrocodone, morphine, oxycodone, or acetaminophen or their excipients; In a participant taking oxycodone CR or morphine SR at screening, is also taking more than 2 doses per day of an IR opioid for breakthrough pain (exclusion does not apply if prior opioid is hydrocodone); Is taking daily acetaminophen at a dose that exceeds 3,000 mg/day, including both acetaminophen and acetaminophen-containing combination products; Has received systemic corticosteroids within 4 weeks before the screening visit; For participant with OA, has received an injection of hyaluronic acid into the reference joint within 4 weeks before the screening visit; Has taken a monoamine oxidase inhibitor within 14 days before the screening visit; Has received an investigational drug or used an invasive investigational medical device within 30 days before the screening visit or is currently enrolled in an investigational study; Has previously participated in this clinical study; Is a woman who is pregnant, breast-feeding, or planning to become pregnant within 2 weeks after the last dose of study drug; Has any planned procedure that would require supplemental analgesics during the time of expected participation in the study; Has any significant pain condition other than chronic LBP or OA that, in the opinion of the investigator, could confound the assessment or self-evaluation of pain; Current diagnosis of fibromyalgia, complex regional pain syndrome, acute spinal cord compression, bowel or bladder dysfunction as a result of cauda equina compression, back pain caused by secondary infection, or pain caused by suspected neoplasm; Have answered "yes" to items 1 and 2 in the Columbia Suicide Severity Rating Scale administered at the screening visit.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Clinton, Utah
Study site
Jacksonville, Florida
Study site
Mandeville, Louisiana
Study site
Metairie, Louisiana
Study site
New Orleans, Louisiana
Study site
Oklahoma City, Oklahoma
Study site
Prairie Village, Kansas
About this study
Official title: An Open-label, Multi-center, Single-arm, Phase IV Clinical Trial Assessing Conversion From Hydrocodone, Oxycodone CR or Morphine SR to Tapentadol ER in Subjects With Moderate to Severe Chronic Low Back or OA Pain of the Hip or Knee
The purpose of this study is to evaluate tapentadol Extended Release (ER) in the treatment of moderate to severe chronic pain in participants with a diagnosis of chronic low back pain (LBP) or osteoarthritis (OA) of the hip or knee after conversion from hydrocodone, oxycodone Controlled Release (CR), and/or morphine Sustained Release (SR).
Read the detailed description
This is a multi-center, single group, open-label (all people know the identity of the intervention) treatment study to describe the overall clinical experience in participants with moderate to severe chronic low back pain or OA pain of the hip or knee, after conversion from hydrocodone, oxycodone CR, and/or morphine SR, using dose-conversion ratios of 1:5, 1:5 and 1:2.5, respectively.
Approximately 150 participants taking hydrocodone, oxycodone CR, and/or morphine SR with baseline pain intensity ≥4 (ie, pain intensity scores averaged over the last 4 days of the screening period on an 11-point numeric rating scale [NRS]) will be converted to an initial dose of tapentadol ER 100, 150 or 200 mg approximately every 12 hours based on their total daily dose of prior opioids. Enrollment of participants in any prior opioid group (hydrocodone, oxycodone CR, and/or morphine SR) may be stopped at any time during the study to ensure adequate representation of each prior opioid.
The study will consist of two periods: screening (1 Week) and treatment (4 weeks). The expected duration of participation for individual participants is approximately 5 weeks, including 4 weeks of active study treatment. The study will include scheduled visits and may also include unscheduled phone calls and site visits for dose adjustment and/or for safety evaluations.
- Being tested
- Nucynta ER
- Keywords
- Chronic Low Back Pain, Osteoarthritis Pain In The Hip or Knee, Oxycodone, Morphine, Hydrocodone, Tapentadol, NUCYNTA ER
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucynta ERDrug
Also called Nucynta Extended Release
100 to 250 mg every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Nucynta ER | Experimental | Nucynta ER will be 100 to 250 mg every 12 hours Receives: Drug: Nucynta ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity from baseline to end of study as measured on an 11-point numeric rating scale (NRS)
The pain intensity NRS is a commonly used pain scale that is a core recommended outcome measure for chronic pain studies. A score of 0 indicates "no pain" and a score of 10 indicates "pain as bad as you can imagine." Change in pain intensity is measured from baseline to the end of treatment.
Measured: Day 1 and Day 29
Secondary outcomes (6)
11-point pain intensity numeric rating scale (NRS) (twice daily) and diary compliance
The pain intensity NRS is a commonly used pain scale that is a core recommended outcome measure for chronic pain studies. A score of 0 indicates "no pain" and a score of 10 indicates "pain as bad as you can imagine."
Measured: Day 1, Day 8, Day 15, Day 22, Day 29
Quality of life as measured by the SF-12v2® Health Survey
The SF-12v2® is a 12-item health survey instrument that is used to evaluate the subject's physical, social, and mental well-being. Results are expressed in terms of 2 composite scores: the Physical Component Scale (PCS) and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100. Lowest scores mean very much below and highest scores mean very much above the general population average.
Measured: Day 8, Day 15, Day 22, Day 29
Pain interference as measured by the Brief Pain Intensity-Short Form (BPI-SF) questionnaire
The BPI-SF is a self-administered, validated tool for the assessment of severity of pain and the impact of pain on daily functions, location of pain, pain medications, and amount of pain relief in the last week. The BPI-SF uses a numeric rating scale (NRS) from 0 to 10, lower score denotes less severity and impact, higher score denotes more severity and impact.
Measured: Day 8, Day 15, Day 22, Day 29
Sleep quality as measured by the Sleep Questionnaire
The 4-item Sleep Questionnaire is a validated instrument including the 4 main concepts that are considered standard and are consistently measured via sleep diaries: latency, time slept, number of awakenings, and quality experienced by the subject during the preceding night.
Measured: Day 1, Day 8, Day 15, Day 22, Day 29
Extent of neuropathic pain as measured by the painDETECT questionnaire (PDQ)
The PDQ is a simple evaluation tool to help identify the presence of neuropathic pain. It consists of 12 questions that ask about the intensity and quality of the patient's pain. A score between 0 and 12 is "negative" (no neuropathic pain component). A score between 19 and 38 is "positive" (presence of neuropathic component)". Scores from 13 to 18 are "unclear".
Measured: Day 8, Day 29
Participant rating of overall treatment status as measured by the patient global impression of change (PGIC)
The PGIC is a questionnaire that assesses the subject's global improvement since starting study treatment. It uses a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2012
- Study completionApr 2013 (estimated)
Why it stopped: It was a business decision to cancel this study in Aug. 2012.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631513
- Sponsor's protocol ID
- CR100757
- Other IDs
- R331333PAI4005
- Status last verified
- Nov 2016
- First submitted
- 27 Jun 2012
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Single-arm, Phase IV Clinical Trial Assessing Conversion From Hydrocodone, Oxycodone CR or Morphine SR to Tapentadol ER in Subjects With Moderate to Severe Chronic Low Back or OA Pain of the Hip or Knee
- ClinicalTrials.gov ID
- NCT01631513
- Acronym / sponsor ID
- CR100757
- Keywords
- Chronic Low Back Pain, Osteoarthritis Pain In The Hip or Knee, Oxycodone, Morphine, Hydrocodone, Tapentadol, NUCYNTA ER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was a business decision to cancel this study in Aug. 2012.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Apr 2013 (estimated)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
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 tapentadol Extended Release (ER) in the treatment of moderate to severe chronic pain in participants with a diagnosis of chronic low back pain (LBP) or osteoarthritis (OA) of the hip or knee after conversion from hydrocodone, oxycodone Controlled Release (CR), and/or morphine Sustained Release (SR).
Detailed description
This is a multi-center, single group, open-label (all people know the identity of the intervention) treatment study to describe the overall clinical experience in participants with moderate to severe chronic low back pain or OA pain of the hip or knee, after conversion from hydrocodone, oxycodone CR, and/or morphine SR, using dose-conversion ratios of 1:5, 1:5 and 1:2.5, respectively.
Approximately 150 participants taking hydrocodone, oxycodone CR, and/or morphine SR with baseline pain intensity ≥4 (ie, pain intensity scores averaged over the last 4 days of the screening period on an 11-point numeric rating scale [NRS]) will be converted to an initial dose of tapentadol ER 100, 150 or 200 mg approximately every 12 hours based on their total daily dose of prior opioids. Enrollment of participants in any prior opioid group (hydrocodone, oxycodone CR, and/or morphine SR) may be stopped at any time during the study to ensure adequate representation of each prior opioid.
The study will consist of two periods: screening (1 Week) and treatment (4 weeks). The expected duration of participation for individual participants is approximately 5 weeks, including 4 weeks of active study treatment. The study will include scheduled visits and may also include unscheduled phone calls and site visits for dose adjustment and/or for safety evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nucynta ER | Experimental | Drug: Nucynta ERNucynta ER will be 100 to 250 mg every 12 hours |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have a clinical diagnosis of knee or hip osteoarthritis (OA) with history of pain at the reference joint or clinical diagnosis of low back pain (LBP) of non malignant origin for at least 3 months before the screening visit; Be taking hydrocodone, oxycodone CR, or morphine SR for the treatment of chronic LBP, or OA of the knee or hip for at least 2 weeks before the screening visit; Have a baseline pain intensity score of ≥4 on an 11-point pain intensity numeric rating scale; Be willing and able to independently communicate pain characteristics, complete all protocol required measurements/assessments without assistance, understand and complete self-administered questionnaires and adhere to the prohibitions and restrictions specified in this protocol.
Key exclusion criteria (1 listed)
- Had surgery in the low back area or the reference joint within 3 months before the screening visit, or will not have fully recovered from surgery by the screening visit, or is expected to require surgical intervention in the low back area or the reference joint during participation in the study; For participants with OA of the hip or knee, has a clinical history and findings at the reference joint suggesting the pain is secondary to crystal-induced, metabolic, infectious, and/or autoimmune disease(s); Has a known history of severe chronic renal insufficiency, severely impaired hepatic function, or alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal; Has a history of seizure disorder, epilepsy, or recurrent seizures; Has any of the following within 1 year before the screening visit: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm; Has a known or suspected history of alcohol abuse in the past 10 years or any history of drug abuse; Has a history of malignancy within 2 years before the screening visit, with the exception of basal cell carcinoma that has been successfully treated; Has significant respiratory depression, acute or severe bronchial asthma, or hypercapnia and paralytic ileus; Has a known history of allergies, hypersensitivity, or contraindication to tapentadol, hydrocodone, morphine, oxycodone, or acetaminophen or their excipients; In a participant taking oxycodone CR or morphine SR at screening, is also taking more than 2 doses per day of an IR opioid for breakthrough pain (exclusion does not apply if prior opioid is hydrocodone); Is taking daily acetaminophen at a dose that exceeds 3,000 mg/day, including both acetaminophen and acetaminophen-containing combination products; Has received systemic corticosteroids within 4 weeks before the screening visit; For participant with OA, has received an injection of hyaluronic acid into the reference joint within 4 weeks before the screening visit; Has taken a monoamine oxidase inhibitor within 14 days before the screening visit; Has received an investigational drug or used an invasive investigational medical device within 30 days before the screening visit or is currently enrolled in an investigational study; Has previously participated in this clinical study; Is a woman who is pregnant, breast-feeding, or planning to become pregnant within 2 weeks after the last dose of study drug; Has any planned procedure that would require supplemental analgesics during the time of expected participation in the study; Has any significant pain condition other than chronic LBP or OA that, in the opinion of the investigator, could confound the assessment or self-evaluation of pain; Current diagnosis of fibromyalgia, complex regional pain syndrome, acute spinal cord compression, bowel or bladder dysfunction as a result of cauda equina compression, back pain caused by secondary infection, or pain caused by suspected neoplasm; Have answered "yes" to items 1 and 2 in the Columbia Suicide Severity Rating Scale administered at the screening visit.
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 |
|---|---|---|
| Nucynta ERAlso: Nucynta Extended Release100 to 250 mg every 12 hours | Drug | Nucynta ER |
Primary outcome
Change in pain intensity from baseline to end of study as measured on an 11-point numeric rating scale (NRS)
Time frame: Day 1 and Day 29
The pain intensity NRS is a commonly used pain scale that is a core recommended outcome measure for chronic pain studies. A score of 0 indicates "no pain" and a score of 10 indicates "pain as bad as you can imagine." Change in pain intensity is measured from baseline to the end of treatment.
6 secondary outcomes
11-point pain intensity numeric rating scale (NRS) (twice daily) and diary compliance
Time frame: Day 1, Day 8, Day 15, Day 22, Day 29
Quality of life as measured by the SF-12v2® Health Survey
Time frame: Day 8, Day 15, Day 22, Day 29
Pain interference as measured by the Brief Pain Intensity-Short Form (BPI-SF) questionnaire
Time frame: Day 8, Day 15, Day 22, Day 29
Sleep quality as measured by the Sleep Questionnaire
Time frame: Day 1, Day 8, Day 15, Day 22, Day 29
Extent of neuropathic pain as measured by the painDETECT questionnaire (PDQ)
Time frame: Day 8, Day 29
Participant rating of overall treatment status as measured by the patient global impression of change (PGIC)
Time frame: Day 29
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nucynta ER in people with Pain and Chronic Back Pain, run by Janssen Scientific Affairs, LLC at 7 sites in United States.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in pain intensity from baseline to end of study as measured on an 11-point numeric rating scale (NRS) (time frame: Day 1 and Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2018.