Trial · NCT00665431
Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
NCT00665431, Phase 3, Completed, POZEN; results first posted 2011-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis. Trials, record NCT00665431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00665431
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
- NCT number
- NCT00665431
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 610 participants, actual
- Lead sponsor
- POZEN
- Conditions
- Osteoarthritis
- Interventions
- PN 400 (VIMOVO), celebrex, Placebo, Rescue Antacid
- First posted
- 2008-04-23
- Last updated
- 2011-12-06
- Results first posted
- 2011-12-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline | Baseline and 12 Weeks | Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function). |
| Primary | Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline | 12 Weeks | WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm). The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function). |
| Primary | Change in Patient Global Assessment (PGA) Subscore From Baseline | 12 Weeks | PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm. |
| Secondary | Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain. | Baseline and Day 7 | For APS-POQ score is the change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference. |
| Secondary | Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline | Week 6 | Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function). |
| Secondary | Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline | Week 6 | WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm). The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function). |
| Secondary | Change in Patient Global Assessment (PGA) Subscore From Baseline | Week 6 | PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm. |
| Secondary | Antacid Tablet Use | 12 weeks | Tablet pill count |
| Secondary | Modified Severity of Dyspepsia Assessment (mSODA) | 12 weeks | Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain. |
| Secondary | Percent of Days With no Heartburn (Heartburn Resolution) | 12 weeks | During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline | Baseline and 12 Weeks | Analysis Population: Baseline + took \>= 1 dose + \>= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward | mm | MEAN |
| PRIMARY | Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline | 12 Weeks | Analysis Population: Baseline + took \>= 1 dose + \>= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward | mm | MEAN |
| PRIMARY | Change in Patient Global Assessment (PGA) Subscore From Baseline | 12 Weeks | Analysis Population: Baseline + took \>= 1 dose + \>= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward | mm | MEAN |
| SECONDARY | Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain. | Baseline and Day 7 | Intent to treat | Units on a scale | MEAN |
| SECONDARY | Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline | Week 6 | Intent to treat | mm | MEAN |
| SECONDARY | Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline | Week 6 | Intent to treat | mm | MEAN |
| SECONDARY | Change in Patient Global Assessment (PGA) Subscore From Baseline | Week 6 | Intent to treat | mm | MEAN |
| SECONDARY | Antacid Tablet Use | 12 weeks | Intent to treat | Tablets per subject | MEAN |
| SECONDARY | Modified Severity of Dyspepsia Assessment (mSODA) | 12 weeks | intent to treat with last observation carried forward | Scores on a scale | MEAN |
| SECONDARY | Percent of Days With no Heartburn (Heartburn Resolution) | 12 weeks | Intent to treat | percent days | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline | (PN 400 (VIMOVO) Twice Daily) | -44.1 | Standard Deviation 27.5 | mm | |
| Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline | (Celebrex 200 mg Once Daily) | -43.6 | Standard Deviation 25.2 | mm | |
| Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline | (Placebo Twice Daily) | -37.3 | Standard Deviation 26.1 | mm | |
| Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline | (PN 400 (VIMOVO) Twice Daily) | -38.7 | Standard Deviation 27.2 | mm | |
| Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline | (Celebrex 200 mg Once Daily) | -37.7 | Standard Deviation 27.5 | mm | |
| Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline | (Placebo Twice Daily) | -30.9 | Standard Deviation 28 | mm | |
| Change in Patient Global Assessment (PGA) Subscore From Baseline | (PN 400 (VIMOVO) Twice Daily) | 27.7 | Standard Deviation 34.8 | mm | |
| Change in Patient Global Assessment (PGA) Subscore From Baseline | (Celebrex 200 mg Once Daily) | 26.4 | Standard Deviation 30.3 | mm | |
| Change in Patient Global Assessment (PGA) Subscore From Baseline | (Placebo Twice Daily) | 22.4 | Standard Deviation 31.3 | mm | |
| Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain. | (PN 400 (VIMOVO) Twice Daily) | -18.8 | Standard Deviation 15.8 | Units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | (PN 400 (VIMOVO) Twice Daily) | 243 | |
| Overall Study | STARTED | (Celebrex 200 mg Once Daily) | 245 | |
| Overall Study | STARTED | (Placebo Twice Daily) | 122 | |
| Overall Study | COMPLETED | (PN 400 (VIMOVO) Twice Daily) | 203 | |
| Overall Study | COMPLETED | (Celebrex 200 mg Once Daily) | 188 | |
| Overall Study | COMPLETED | (Placebo Twice Daily) | 98 | |
| Overall Study | NOT COMPLETED | (PN 400 (VIMOVO) Twice Daily) | 40 | |
| Overall Study | NOT COMPLETED | (Celebrex 200 mg Once Daily) | 57 | |
| Overall Study | NOT COMPLETED | (Placebo Twice Daily) | 24 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dyspepsia | Gastrointestinal disorders | (PN 400 (VIMOVO) Twice Daily) | 28 | 243 | 28 |
| other | Dyspepsia | Gastrointestinal disorders | (Celebrex 200 mg Once Daily) | 33 | 245 | 33 |
| other | Dyspepsia | Gastrointestinal disorders | (Placebo Twice Daily) | 16 | 122 | 16 |
| other | Diarrhea | Gastrointestinal disorders | (PN 400 (VIMOVO) Twice Daily) | 12 | 243 | 12 |
| other | Diarrhea | Gastrointestinal disorders | (Celebrex 200 mg Once Daily) | 6 | 245 | 6 |
| other | Diarrhea | Gastrointestinal disorders | (Placebo Twice Daily) | 6 | 122 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | (PN 400 (VIMOVO) Twice Daily) | 10 | 243 | 10 |
| other | Abdominal pain upper | Gastrointestinal disorders | (Celebrex 200 mg Once Daily) | 12 | 245 | 12 |
| other | Abdominal pain upper | Gastrointestinal disorders | (Placebo Twice Daily) | 6 | 122 | 6 |
| other | Constipation | Gastrointestinal disorders | (PN 400 (VIMOVO) Twice Daily) | 8 | 243 | 8 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | (PN 400 (VIMOVO) Twice Daily) | ||
| Total, all-cause mortality | (Celebrex 200 mg Once Daily) | ||
| Total, all-cause mortality | (Placebo Twice Daily) | ||
| Total, other adverse events | (PN 400 (VIMOVO) Twice Daily) | 111 | 243 |
| Total, other adverse events | (Celebrex 200 mg Once Daily) | 107 | 245 |
| Total, other adverse events | (Placebo Twice Daily) | 53 | 122 |
| Total, serious adverse events | (PN 400 (VIMOVO) Twice Daily) | 3 | 243 |
| Total, serious adverse events | (Celebrex 200 mg Once Daily) | 3 | 245 |
| Total, serious adverse events | (Placebo Twice Daily) | 1 | 122 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00665431
GET https://conductscience.org/api/trials/v1/NCT00665431/results?page=2