Trial · NCT01018680
A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis
NCT01018680, Phase 3, Completed, Eli Lilly and Company; results first posted 2012-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis. Trials, record NCT01018680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01018680
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis
- NCT number
- NCT01018680
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 524 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoarthritis Knee Pain
- Interventions
- Duloxetine, Placebo
- First posted
- 2009-11-25
- Last updated
- 2012-10-05
- Results first posted
- 2012-10-05
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain ratings using an 11-point numeric rating scale, with scores from 0 (indicating "no pain") to 10 (indicating "the worst possible pain"). The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), week, treatment\*week, and baseline\*week. |
| Secondary | Patient Global Impression of Improvement (PGI-I) at 8 Weeks | 8 weeks (blinded endpoint) | A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares Mean estimates were adjusted for baseline value of Patient Global Impression of Severity (PGI-S), treatment, investigator (pooled), visit, and treatment\*visit. The PGI-S measures participant's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill). |
| Secondary | Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Self-administered questionnaire captures elements of pain, stiffness, and physical disability in participants with osteoarthritis of the knee and/or hip. Index has 24 questions (5 on pain, 2 on stiffness, 17 on physical function). Each question uses a 5-point numeric rating scale ranging from 0 (none) to 4 (extreme). Pain scores range: 0 to 20. Stiffness scores range: 0 to 8. Physical function scores range: 0 to 68. Higher scores=greater impairment. Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment\*visit, and baseline value\*visit. |
| Secondary | Change From Baseline in the Weekly Mean of the 24-Hour Night Pain and Worst Pain Scores at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Weekly mean 24-hour night pain and worst pain values are calculated from the participant's daily assessments of pain at night and worst pain during the previous 24 hours on an 11-point numeric rating scale, with scores from 0 (indicating "no pain") to 10 (indicating "the worst possible pain"). The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), week, treatment\*week, and baseline\*week. |
| Secondary | Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) Scores at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Measures pain severity and pain interference with function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Mean interference is the average across the 7 interference items. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment\*visit, and baseline\*visit. |
| Secondary | Change From Baseline in the Clinical Global Impression of Severity (CGI-S) at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | The CGI-S scale evaluates the severity of illness at the time of assessment. The scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-S must be administered by a study physician in the presence of the participant or after having been in the presence of the participant. The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), visit, treatment\*visit, and baseline\*visit. |
| Secondary | Change From Baseline in the Patient Global Assessment of Illness (PGAI) at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | The PGAI is a participant-rated measure of the severity of osteoarthritis (OA) of the knee the participant has experienced in the past week as indicated on an 11-point numeric rating scale, with scores ranging from 0 to 10, where greater numbers reflect greater severity. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment\*visit, and baseline\*visit. |
| Secondary | Change From Baseline in the Profile of Mood States-Brief Form (BPOMS) Total and Subscale Scores at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | 30-item BPOMS measures positive and negative aspects of mood states (item score: 0=not at all to 4=extremely). 5 negative factors: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusion-bewilderment; 1 positive factor: vigor-activity. Factor scores range: 0 to 20; high scores=negative mood (positive mood for vigor). Total score=sum of 5 negative factor scores minus vigor score; range: -20=least disturbed to 100=most disturbed. Least Squares Mean estimates adjusted for baseline value, treatment, investigator (pooled), visit, treatment\*visit, and baseline value\*visit. |
| Secondary | Percentage of Participants Using Acetaminophen Weekly During the 10-Week Treatment Period | Baseline through 10 weeks (blinded endpoint) | The Least Squares (LS) Mean percentage estimates of participants using acetaminophen was determined during each week individually over the full 10-week treatment period based on participant's daily Yes/No assessments for the use of acetaminophen. The LS Mean estimates for the main effect of treatment (average weekly use) were adjusted for baseline value, treatment, investigator (pooled), week, and treatment\*week. |
| Secondary | Percentage of Responders as Assessed by the Osteoarthritis Research Society International (OARSI) Response Criteria up to 8 Weeks | Up to 8 weeks (blinded endpoint) | OARSI response is composite Yes/No response assessed at 8 weeks based on decrease in 24-hour average pain ratings, range: 0 ("no pain") to 10 ("worst possible pain"), improvement in functioning (using WOMAC physical function scores, range: 0 \[no difficulty\] to 68 \[extreme difficulty\]), and improvement in participant's impression of illness (using PGAI scores, range: 0 to 10; 10=greatest severity). OARSI responder=large response in pain or function components (50% relative and 20% absolute improvement), or moderate response (20% relative and 10% absolute improvement) in 2 of 3 components. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean 24-hour average pain value were included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Improvement (PGI-I) at 8 Weeks | 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline PGI-S rating and at least 1 post-baseline PGI-I rating were included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline WOMAC value were included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Weekly Mean of the 24-Hour Night Pain and Worst Pain Scores at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline night/worst pain value and at least 1 post-baseline weekly mean 24-hour night/worst pain value were included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) Scores at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S/BPI-I value were included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Clinical Global Impression of Severity (CGI-S) at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline CGI-S value were included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Patient Global Assessment of Illness (PGAI) at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline PGAI value were included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Profile of Mood States-Brief Form (BPOMS) Total and Subscale Scores at 8 Weeks | Baseline, 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPOMS value were included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Using Acetaminophen Weekly During the 10-Week Treatment Period | Baseline through 10 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly acetaminophen use value were included in the analysis. | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders as Assessed by the Osteoarthritis Research Society International (OARSI) Response Criteria up to 8 Weeks | Up to 8 weeks (blinded endpoint) | Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline OARSI response value, last-observation-carried forward (LOCF) based on values of each of the 3 components listed in the outcome measure description were included in the analysis. | percentage of responders | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks | Placebo | -1.55 | Standard Error 0.11 | units on a scale | |
| Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks | Duloxetine | -2.46 | Standard Error 0.11 | units on a scale | |
| Patient Global Impression of Improvement (PGI-I) at 8 Weeks | Placebo | 2.93 | Standard Error 0.09 | units on a scale | |
| Patient Global Impression of Improvement (PGI-I) at 8 Weeks | Duloxetine | 2.33 | Standard Error 0.09 | units on a scale | |
| Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks | Placebo | WOMAC Physical Disability Score (n=253, 251) | -10.25 | Standard Error 0.82 | units on a scale |
| Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks | Duloxetine | WOMAC Physical Disability Score (n=253, 251) | -15.09 | Standard Error 0.81 | units on a scale |
| Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks | Placebo | WOMAC Pain Score | -3.13 | Standard Error 0.24 | units on a scale |
| Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks | Duloxetine | WOMAC Pain Score | -4.41 | Standard Error 0.23 | units on a scale |
| Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks | Placebo | WOMAC Stiffness Score | -1.45 | Standard Error 0.12 | units on a scale |
| Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks | Duloxetine | WOMAC Stiffness Score | -1.88 | Standard Error 0.11 | units on a scale |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 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 | 260 | |
| Overall Study | STARTED | Duloxetine | 264 | |
| Overall Study | COMPLETED | Placebo | 199 | |
| Overall Study | COMPLETED | Duloxetine | 189 | |
| Overall Study | NOT COMPLETED | Placebo | 61 | |
| Overall Study | NOT COMPLETED | Duloxetine | 75 |
Source ClinicalTrials.gov
Adverse events122
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 | Palpitations | Cardiac disorders | Placebo | 2 | 260 | 2 |
| other | Palpitations | Cardiac disorders | Duloxetine | 4 | 264 | 4 |
| other | Vision blurred | Eye disorders | Placebo | 1 | 260 | 1 |
| other | Vision blurred | Eye disorders | Duloxetine | 5 | 264 | 5 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 0 | 260 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Duloxetine | 5 | 264 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 260 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Duloxetine | 4 | 264 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 260 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Duloxetine | 7 | 264 | 7 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Duloxetine | ||
| Total, other adverse events | Placebo | 129 | 260 |
| Total, other adverse events | Duloxetine | 167 | 264 |
| Total, serious adverse events | Placebo | 3 | 260 |
| Total, serious adverse events | Duloxetine | 5 | 264 |
Source ClinicalTrials.gov
Papers4
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Duloxetine vs Placebo: serious adverse events |
Source 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/NCT01018680
GET https://conductscience.org/api/trials/v1/NCT01018680/results?page=2