Trial · NCT01799213
Discontinuing NSAIDs in Veterans With Knee Osteoarthritis
NCT01799213, Phase 2, Completed, VA Office of Research and Development; results first posted 2019-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Discontinuing NSAIDs in Veterans With Knee Osteoarthritis. Trials, record NCT01799213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01799213
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Discontinuing NSAIDs in Veterans With Knee Osteoarthritis
- NCT number
- NCT01799213
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 490 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Knee Osteoarthritis
- Interventions
- Meloxicam 15 mg po QD, Cognitive Behavioral Therapy
- First posted
- 2013-02-26
- Last updated
- 2023-07-27
- Results first posted
- 2019-12-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Endpoint: WOMAC Pain Score (Likert Scale Version) at 4 Weeks | 4 Weeks | The WOMAC pain score has a possible score range of 0-20 for Pain and higher scores indicate worse pain. The WOMAC pain scale consists of 5 questions that ask about pain during walking, stair use, lying in bed at night, sitting, and standing. Each question is scored on a 5-point scale, where 0 = None, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain, and 4 = Very severe pain. Total pain scores range from 0 to 20 with higher scores reflecting worse pain. The WOMAC also includes a lower extremity disability scale. Both the pain scale and disability scale (17 items) can be analyzed separately. |
| Secondary | Area Under the Curve (AUC) of the WOMAC Pain Scale Score Over 14 Weeks | 14 Weeks | The AUC is a commonly used measure that combines multiple measurements over a specific time interval into a single index. The AUC provides a single score that quantifies each participant's total WOMAC score across the repeated measurements. The AUC is valid regardless of increases or decreases in reported pain over time. In this case, the possible range is 0-20, with higher scores indicating worse pain. |
| Secondary | Lower Extremity Disability | 14 weeks | Lower extremity disability: Lower extremity functional outcomes will be measured using the WOMAC disability scale. The physical disability scale contains 17 items that assess the amount of difficulty subjects say they have with climbing stairs, rising from a chair, walking, and other activities of daily living. Responses are measured and scored in the same way as the pain scale. The WOMAC lower extremity disability score has a possible score range of 0-68 and higher scores indicate worse functional limitation. |
| Secondary | Global Impression of Change | 14 weeks | A balanced 5-point scale (rated 1 = Much better to 5 = Much worse) asking subjects to rate their change (if any) in pain since starting the study. The possible range of scores is 1 to 5. |
| Secondary | Adherence to Study Medication (Assessed in Weeks Adherent) | Weekly, for duration of observation period (14 weeks) | * Over the past week, how many days did you use the study drug for your knee pain? * Over the past week, how many days did you use Tylenol or acetaminophen for your knee pain? * Over the past week, how many days did you use other medications that were prescribed by one of your doctors for your knee pain? * Over the past week, how many days did you use other medications, creams or supplements that you got without a prescription for your knee pain? * Over the past week, how many days did you use any medications for a different problem or type of pain (e.g. headache)? Results reported as percentage of study weeks with perfect participant adherence to study medications, with higher percentages indicating higher adherence. |
| Secondary | Adherence to Study Medication (Assessed in % of Weeks With Perfect Adherence) | Weekly, for duration of observation period (14 weeks) | * Over the past week, how many days did you use the study drug for your knee pain? * Over the past week, how many days did you use Tylenol or acetaminophen for your knee pain? * Over the past week, how many days did you use other medications that were prescribed by one of your doctors for your knee pain? * Over the past week, how many days did you use other medications, creams or supplements that you got without a prescription for your knee pain? * Over the past week, how many days did you use any medications for a different problem or type of pain (e.g. headache)? Results reported as percentage of study weeks with perfect participant adherence to study medications, with higher percentages indicating higher adherence. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Endpoint: WOMAC Pain Score (Likert Scale Version) at 4 Weeks | 4 Weeks | The WOMAC pain score was available for 84% (152/180) of participants in the placebo group and 92% (169/184) of participants in the meloxicam group four weeks post-randomization. | units on a scale | MEAN |
| SECONDARY | Area Under the Curve (AUC) of the WOMAC Pain Scale Score Over 14 Weeks | 14 Weeks | Those with no post-randomization pain measurements (n= 5 in meloxicam group, n= 4 in placebo) were excluded from all analyses of pain, leaving 355 (98%) participants for this analysis. | units on a scale*week | MEAN |
| SECONDARY | Lower Extremity Disability | 14 weeks | WOMAC lower extremity disability scores were available in 336 (92%) participants at the end of Phase 2. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Global Impression of Change | 14 weeks | Global impression of change was available in 336 (92%) participants at the end of Phase 2 | score on a scale | MEAN |
| SECONDARY | Adherence to Study Medication (Assessed in Weeks Adherent) | Weekly, for duration of observation period (14 weeks) | All eligible subjects with any adherence data reported. | Weeks Adherent | MEDIAN |
| SECONDARY | Adherence to Study Medication (Assessed in % of Weeks With Perfect Adherence) | Weekly, for duration of observation period (14 weeks) | All eligible subjects with any adherence data reported. | % weeks with perfect adherences | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Endpoint: WOMAC Pain Score (Likert Scale Version) at 4 Weeks | Placebo Followed by CBT | 8.08 | Standard Error 0.3 | units on a scale | |
| Primary Endpoint: WOMAC Pain Score (Likert Scale Version) at 4 Weeks | Meloxicam | 6.73 | Standard Error 0.28 | units on a scale | |
| Area Under the Curve (AUC) of the WOMAC Pain Scale Score Over 14 Weeks | Placebo | 7.48 | Standard Error 0.21 | units on a scale*week | |
| Area Under the Curve (AUC) of the WOMAC Pain Scale Score Over 14 Weeks | Meloxicam | 6.43 | Standard Error 0.21 | units on a scale*week | |
| Lower Extremity Disability | Active Treatment | 18.8 | Standard Error 0.9 | score on a scale | |
| Lower Extremity Disability | Placebo | 19.7 | Standard Error 0.9 | score on a scale | |
| Global Impression of Change | Placebo | 2.15 | Standard Error 0.08 | score on a scale | |
| Global Impression of Change | Meloxicam | 2.30 | Standard Error 0.08 | score on a scale | |
| Adherence to Study Medication (Assessed in Weeks Adherent) | Placebo | 4 | Inter-Quartile Range 3 to 4 | Weeks Adherent | |
| Adherence to Study Medication (Assessed in Weeks Adherent) | Active Treatment | 13 | Inter-Quartile Range 11 to 14 | Weeks Adherent |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Followed by CBT | 180 | |
| Overall Study | STARTED | Active Treatment With Meloxicam | 184 | |
| Overall Study | COMPLETED | Placebo Followed by CBT | 173 | |
| Overall Study | COMPLETED | Active Treatment With Meloxicam | 178 | |
| Overall Study | NOT COMPLETED | Placebo Followed by CBT | 7 | |
| Overall Study | NOT COMPLETED | Active Treatment With Meloxicam | 6 |
Source ClinicalTrials.gov
Adverse events10
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 |
|---|---|---|---|---|---|---|
| serious | Bleeding hemorrhoid | Gastrointestinal disorders | Placebo | 0 | 180 | 0 |
| serious | Bleeding hemorrhoid | Gastrointestinal disorders | Meloxicam | 1 | 184 | 1 |
| serious | Chest Pain | Cardiac disorders | Placebo | 1 | 180 | 1 |
| serious | Chest Pain | Cardiac disorders | Meloxicam | 2 | 184 | 2 |
| serious | ischemic stroke | Vascular disorders | Placebo | 1 | 180 | 1 |
| serious | ischemic stroke | Vascular disorders | Meloxicam | 0 | 184 | 0 |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 1 | 180 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Meloxicam | 0 | 184 | 0 |
| serious | Arm celluitis | Infections and infestations | Placebo | 0 | 180 | 0 |
| serious | Arm celluitis | Infections and infestations | Meloxicam | 1 | 184 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 180 |
| Total, all-cause mortality | Meloxicam | 0 | 184 |
| Total, other adverse events | Placebo | 0 | 180 |
| Total, other adverse events | Meloxicam | 0 | 184 |
| Total, serious adverse events | Placebo | 3 | 180 |
| Total, serious adverse events | Meloxicam | 4 | 184 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Meloxicam vs Placebo: deaths from any cause | Trial comparisons |
| Meloxicam vs Placebo: 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/NCT01799213
GET https://conductscience.org/api/trials/v1/NCT01799213/registered