Pain, PostoperativePhase 3NCT00726388
An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
A Phase 3 study testing DIC075V (intravenous diclofenac sodium) in people with Pain, Postoperative, run by Pfizer at 46 sites in United States.
Trial summary
This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- DIC075V (intravenous diclofenac sodium)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 46 sitesUnited States
- Study dates
- 15 Sep 2008to 8 May 2009
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days
- Expected stay > 48 hrs
Who cannot join
- bilirubin > 2.5 mg/dl
- prothrombin time is > 20% above the upper limit of normal
- serum creatinine is > 1.9 mg/dl at screening.
- known allergy or hypersensitivity to diclofenac, other NSAIDs,
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Albany Medical Center
Albany, New York, 12208
Allegheny Pain Management
Altoona, Pennsylvania, 16602
University of Orthopedics Center
Altoona, Pennsylvania, 16602
American Clinical Research
Aurora, Colorado
Vertex
Bakersfield, California, 93311
West Alabama Research, LLC
Birmingham, Alabama, 35209
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
The Ohio State University Medical Center
Columbus, Ohio, 43210
Soapstone Center for Clinical Research
Decatur, Georgia, 33034
Colorado Orthopedic Consultants
Englewood, Colorado, 80110
Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
Florence, Alabama, 35630
Lotus Clinical Research
Glendale, California, 91206
Great Falls Clinic, LLP
Great Falls, Montana, 59405
Orthopedic Associates of Hartford
Hartford, Connecticut, 06106
Comprehensive Pain Specialists, PLLC
Hendersonville, Tennessee, 37075
Nature Coast Clinical Research
Inverness, Florida, 34452
Ilumina Clinical Associates
Johnstown, Pennsylvania, 15504
Ilumina Clinical Associates
Johnstown, Pennsylvania, 15904
University of Kansas Medical Center Department of Anesthesiology
Kansas City, Kansas, 66160
Physicians Clinical Research
Laguna Hills, California, 92653
Sunrise Medical Research, Inc.
Lauderdale Lakes, Florida
Teton Research, LLC
Little Rock, Arkansas, 72205
National Institute of Clinical Research
Los Angeles, California, 90017
Validity Research
Merriam, Kansas, 66204
Horizon Research Group
Mobile, Alabama, 36608
Drug Research and Analysis Corp.
Montgomery, Alabama, 36106
Jackson Hospital
Montgomery, Alabama, 36106
JRSI Foundation The center for Hip and Knee Surgery
Mooresville, Indiana, 46158
Tulane Univ. Medical Center
New Orleans, Louisiana, 70113
Lotus Clinical Research
Pasadena, California, 91105
Pensacola Research Consultants
Pensacola, Florida, 32504
Pivotal Clinical Research
Peoria, Arizona, 85381
Precision Trials
Phoenix, Arizona, 85032
UPMC Presbyterian-Shadyshide Hospital
Pittsburgh, Pennsylvania, 15232
UPMC-St. Margaret's Hospital
Pittsburgh, Pennsylvania, 15232
Endeavor Clinical Trials
San Antonio, Texas, 78229
Interventional Pain Management
San Antonio, Texas, 78258
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Helen Keller Memorial Hospital
Sheffield, Alabama, 35660
Somerset Hospital
Somerset, Pennsylvania, 15501
University Orthopedics Center
State College, Pennsylvania, 16801
Staten Island University Hospital
Staten Island, New York, 10305
American Clinical Research Services
Steamboat Springs, Colorado, 80487
Florida Orthopedic Institute
Tampa, Florida, 33637
Scott & White Clinic / Texas A&M Health Science Center
Temple, Texas, 76508
North Coast Women's Care
Vista, California, 92083
About this study
Official title: An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study Of Repeat-Doses Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.
Read the detailed description
This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.
- Conditions
- Pain, Postoperative
- Being tested
- DIC075V (intravenous diclofenac sodium)
- Keywords
- safety, diclofenac, pain, postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIC075V (intravenous diclofenac sodium)Drug
multiple doses up to 5 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days Receives: Drug: DIC075V (intravenous diclofenac sodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.
Measured: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Number of Participants Who Took at Least 1 Concomitant Medication
Concomitant medications were medications that were taken concurrently on or after first dose of study drug.
Measured: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Number of Participants With Abnormal Urinalysis Findings
Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.
Measured: Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Measured: Baseline (Day 1, immediately before dosing)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Measured: Study discharge/early termination (maximum up to Day 5)
Change From Baseline in Blood Pressure at Study Discharge/Early Termination
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Measured: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Change From Baseline in Blood Pressure at Clinic Follow-up Visit
Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Measured: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Change From Baseline in Respiratory Rate at Study Discharge/Early Termination
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Measured: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Change From Baseline in Respiratory Rate at Clinic Follow-up Visit
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Measured: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Change From Baseline in Heart Rate at Study Discharge/Early Termination
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Measured: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Change From Baseline in Heart Rate at Clinic Follow-up Visit
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Measured: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Number of Participants With Wound Assessment at Study Discharge/Early Termination
Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category "Not Done" for participants with no wound assessment other than the reason 'missing' and category "Missing", where participants were missing for wound assessment.
Measured: Study discharge/early termination (maximum up to Day 5)
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline
Thrombophlebitis assessment evaluation was done using following grades: 0 equals to (=) no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Measured: Baseline (Day 1, immediately before dosing)
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination
Thrombophlebitis assessment evaluation was done using following grades: 0= no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Measured: Study discharge/early termination (maximum up to Day 5)
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening
Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Measured: Screening (0 to 21 days prior to surgery)
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit
Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Measured: Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study start15 Sep 2008
- Primary completion8 May 2009
- Study completion8 May 2009
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 Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726388
- Sponsor's protocol ID
- DFC-010
- Other IDs
- C1211011
- Status last verified
- Sep 2021
- First submitted
- 29 Jul 2008
- Last updated
- 13 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Publications
Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
PubMed 29492863
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study Of Repeat-Doses Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
- ClinicalTrials.gov ID
- NCT00726388
- Acronym / sponsor ID
- DFC-010
- Conditions
- Pain, Postoperative
- Keywords
- safety, diclofenac, pain, postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2008 (actual)
- Primary completion
- 8 May 2009 (actual)
- Study completion
- 8 May 2009 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Posted 13 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.
Detailed description
This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: DIC075V (intravenous diclofenac sodium)IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days
- Expected stay > 48 hrs
Key exclusion criteria (4 listed)
- bilirubin > 2.5 mg/dl
- prothrombin time is > 20% above the upper limit of normal
- serum creatinine is > 1.9 mg/dl at screening.
- known allergy or hypersensitivity to diclofenac, other NSAIDs,
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 |
|---|---|---|
| DIC075V (intravenous diclofenac sodium)multiple doses up to 5 days | Drug | A |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.
Number of Participants Who Took at Least 1 Concomitant Medication
Time frame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Concomitant medications were medications that were taken concurrently on or after first dose of study drug.
Number of Participants With Abnormal Urinalysis Findings
Time frame: Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)
Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline
Time frame: Baseline (Day 1, immediately before dosing)
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination
Time frame: Study discharge/early termination (maximum up to Day 5)
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Change From Baseline in Blood Pressure at Study Discharge/Early Termination
Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Change From Baseline in Blood Pressure at Clinic Follow-up Visit
Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Change From Baseline in Respiratory Rate at Study Discharge/Early Termination
Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Change From Baseline in Respiratory Rate at Clinic Follow-up Visit
Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Change From Baseline in Heart Rate at Study Discharge/Early Termination
Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Change From Baseline in Heart Rate at Clinic Follow-up Visit
Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Number of Participants With Wound Assessment at Study Discharge/Early Termination
Time frame: Study discharge/early termination (maximum up to Day 5)
Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category "Not Done" for participants with no wound assessment other than the reason 'missing' and category "Missing", where participants were missing for wound assessment.
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline
Time frame: Baseline (Day 1, immediately before dosing)
Thrombophlebitis assessment evaluation was done using following grades: 0 equals to (=) no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination
Time frame: Study discharge/early termination (maximum up to Day 5)
Thrombophlebitis assessment evaluation was done using following grades: 0= no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening
Time frame: Screening (0 to 21 days prior to surgery)
Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit
Time frame: Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29492863Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
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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.
Pfizer CT.gov Call Center study director
Pfizer
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DIC075V (intravenous diclofenac sodium) in people with Pain, Postoperative, run by Pfizer at 46 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 2 inclusion and 4 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 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 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 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 13 Oct 2021). 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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)). The study lists 16 primary outcomes in all. 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 NCT00726388, 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 13 Oct 2021.