Trial · NCT00790985
Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee
NCT00790985, Not applicable, Completed, Primus Pharmaceuticals; results first posted 2022-11-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee. Trials, record NCT00790985. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790985
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee
- NCT number
- NCT00790985
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 223 participants, actual
- Lead sponsor
- Primus Pharmaceuticals
- Conditions
- Osteoarthritis of Knee
- Interventions
- flavocoxid, Naproxen
- First posted
- 2008-11-14
- Last updated
- 2022-11-01
- Results first posted
- 2022-11-01
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12. | As measured at Baseline and Week 12 | WOMAC is a composite of subscales: pain - 5 questions, stiffness - 2 questions, physical function - 17 questions. Subject answers each question as none=0, slight=1, moderate=2, very=3 and extreme=4 of pain, stiffness and difficulty of function. Scores for each subscale are summed, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).The higher the score of the units on the scale, the better the outcome. For each individual subject, the percent change from baseline to Week 12 in the WOMAC composite score is calculated as 100 x (week 12 minus baseline)/baseline. The higher the percent change, the better the outcome. The percent changes from baseline to Week 12 are then compared between Flavocoxid and Naproxen. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12. | As measured at Baseline and Week 12 | percentage of change | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12. | Naproxen | 85.75 | Standard Deviation 9.83 | percentage of change | |
| Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12. | Flavocoxid 500 mg | 69.97 | Standard Deviation 7.34 | percentage of change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flavocoxid 500 mg | 108 | |
| Overall Study | STARTED | Naproxen 500 mg | 115 | |
| Overall Study | COMPLETED | Flavocoxid 500 mg | 106 | |
| Overall Study | COMPLETED | Naproxen 500 mg | 114 | |
| Overall Study | NOT COMPLETED | Flavocoxid 500 mg | 2 | |
| Overall Study | NOT COMPLETED | Naproxen 500 mg | 1 |
Source ClinicalTrials.gov
Adverse events4
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 | nausea dyspepsia | Gastrointestinal disorders | Flavocoxid 500 mg | 21 | 108 | 21 |
| other | nausea dyspepsia | Gastrointestinal disorders | Naproxen 500 mg | 39 | 115 | 39 |
| other | edema | Vascular disorders | Flavocoxid 500 mg | 2 | 108 | 2 |
| other | edema | Vascular disorders | Naproxen 500 mg | 10 | 115 | 10 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flavocoxid 500 mg | 0 | 108 |
| Total, all-cause mortality | Naproxen 500 mg | 0 | 115 |
| Total, other adverse events | Flavocoxid 500 mg | 21 | 108 |
| Total, other adverse events | Naproxen 500 mg | 39 | 115 |
| Total, serious adverse events | Flavocoxid 500 mg | 0 | 108 |
| Total, serious adverse events | Naproxen 500 mg | 0 | 115 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Flavocoxid 500 mg vs Naproxen 500 mg: deaths from any cause | Trial comparisons |
| Flavocoxid 500 mg vs Naproxen 500 mg: serious adverse events | Trial comparisons |
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/NCT00790985
GET https://conductscience.org/api/trials/v1/NCT00790985/registered