Trial · NCT00945945
A Study of Duloxetine in Patients With Osteoarthritis Knee Pain
NCT00945945, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-03-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Duloxetine in Patients With Osteoarthritis Knee Pain. Trials, record NCT00945945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00945945
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Duloxetine in Patients With Osteoarthritis Knee Pain
- NCT number
- NCT00945945
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 424 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoarthritis Knee Pain
- Interventions
- Duloxetine (DLX), Placebo (PLA)
- First posted
- 2009-07-24
- Last updated
- 2011-03-08
- Results first posted
- 2011-03-08
- Limitations and caveats
Due to a package labeling error, study drug was incorrectly administered to all patients in both treatment groups. This compromised the integrity of the entire study and rendered planned comparisons between duloxetine and placebo invalid.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score | Baseline, 13 weeks | A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-defined treatment groups were compromised. The results from each mixed-treatment group are presented. |
| Secondary | Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale | Baseline through 13 weeks | C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. |
| Secondary | Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score | Baseline, 13 weeks | A scale that measures the patient'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). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented. |
| Secondary | Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score | baseline, 13 weeks | The WOMAC index (pain, stiffness, physical function subscales) was completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented. |
| Secondary | Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale | Baseline, 13 weeks | Self-reported scale measuring pain severity. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Four questions assess worst pain, least pain, and average pain in the past 24 hours, and pain right now. Total score ranges from 0-40. Due to the nature of a study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented. |
| Secondary | Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score | Baseline, 13 weeks | Interference scores range from 0 (does not interfere) to 10 (completely interferes) on 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Total score ranges from 0-70. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented. |
| Secondary | Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S) | Baseline, 13 weeks | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented. |
| Secondary | Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version | Baseline, 13 weeks | An 11-item questionnaire to individually and jointly assess intermittent and constant pain. Questions assess intensity and impact of pain on activity and emotion. Each item is scored from 0 to 4; higher values indicate higher severity. Total Pain score ranges from 0-44. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented. |
| Secondary | Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS) | Baseline, 13 weeks | BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0-20. Total score = sum of all factor scores minus vigor score. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented. |
| Secondary | Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D) | Baseline, 13 weeks | Patients rate their health state in 5 domains: mobility, self-care, usual activities, pain, and mood. Score between 1-3 is generated for each domain which is mapped to single index score. Index ranges between 0-1; higher scores indicate better health perceived by patient. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score | Baseline, 13 weeks | Number of randomized participants with a non-missing baseline and BOCF endpoint. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale | Baseline through 13 weeks | All randomized participants. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score | Baseline, 13 weeks | participants | MEAN | |
| SECONDARY | Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score | baseline, 13 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale | Baseline, 13 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score | Baseline, 13 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S) | Baseline, 13 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version | Baseline, 13 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS) | Baseline, 13 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D) | Baseline, 13 weeks | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score | DLX30-PLA | Baseline | 6.00 | Standard Deviation 1.28 | units on a scale |
| Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score | PLA-DLX60 | Baseline | 6.10 | Standard Deviation 1.31 | units on a scale |
| Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score | DLX30-PLA | Change from Baseline to Endpoint (BOCF) | -1.93 | Standard Deviation 2.23 | units on a scale |
| Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score | PLA-DLX60 | Change from Baseline to Endpoint (BOCF) | -2.34 | Standard Deviation 2.30 | units on a scale |
| Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale | DLX30-PLA | Ideation: Wish to be dead | 1 | participants | |
| Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale | PLA-DLX60 | Ideation: Wish to be dead | 0 | participants | |
| Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale | DLX30-PLA | Ideation: Non-specific active suicidal thoughts | 0 | participants | |
| Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale | PLA-DLX60 | Ideation: Non-specific active suicidal thoughts | 0 | participants | |
| Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale | DLX30-PLA | Ideation: Active suicidal ideation without intent | 0 | participants | |
| Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale | PLA-DLX60 | Ideation: Active suicidal ideation without intent | 0 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DLX30-PLA | 207 | |
| Overall Study | STARTED | PLA-DLX60 | 217 | |
| Overall Study | COMPLETED | DLX30-PLA | 171 | |
| Overall Study | COMPLETED | PLA-DLX60 | 162 | |
| Overall Study | NOT COMPLETED | DLX30-PLA | 36 | |
| Overall Study | NOT COMPLETED | PLA-DLX60 | 55 |
Source ClinicalTrials.gov
Adverse events34
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 | Constipation | Gastrointestinal disorders | DLX30-PLA | 7 | 207 | 7 |
| other | Constipation | Gastrointestinal disorders | PLA-DLX60 | 12 | 217 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | DLX30-PLA | 7 | 207 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | PLA-DLX60 | 14 | 217 | 14 |
| other | Dry mouth | Gastrointestinal disorders | DLX30-PLA | 11 | 207 | 11 |
| other | Dry mouth | Gastrointestinal disorders | PLA-DLX60 | 19 | 217 | 20 |
| other | Nausea | Gastrointestinal disorders | DLX30-PLA | 21 | 207 | 21 |
| other | Nausea | Gastrointestinal disorders | PLA-DLX60 | 41 | 217 | 43 |
| other | Fatigue | General disorders | DLX30-PLA | 3 | 207 | 3 |
| other | Fatigue | General disorders | PLA-DLX60 | 17 | 217 | 17 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DLX30-PLA | ||
| Total, all-cause mortality | PLA-DLX60 | ||
| Total, other adverse events | DLX30-PLA | 105 | 207 |
| Total, other adverse events | PLA-DLX60 | 143 | 217 |
| Total, serious adverse events | DLX30-PLA | 3 | 207 |
| Total, serious adverse events | PLA-DLX60 | 2 | 217 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| DLX30-PLA vs PLA-DLX60: 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/NCT00945945
GET https://conductscience.org/api/trials/v1/NCT00945945/results?page=2