Trial · NCT02248480
A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan
NCT02248480, Phase 3, Completed, Eli Lilly and Company; results first posted 2017-01-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan. Trials, record NCT02248480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02248480
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan
- NCT number
- NCT02248480
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 354 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Duloxetine, Placebo
- First posted
- 2014-09-25
- Last updated
- 2019-09-26
- Results first posted
- 2017-01-16
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score | Baseline, Week 14 | Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates. |
| Secondary | Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement) | Baseline, 14 Weeks | Patient's Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates. |
| Secondary | Change From Baseline on the Clinical Global Impression of Severity (CGI-S) | Baseline, Week 14 | CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates. |
| Secondary | Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) | Baseline, Week 14 | 36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome \[(Raw score) - min{raw score}\] / (max {raw score} - min{raw score}) x 100\]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate. |
| Secondary | Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score | Baseline, Week 14 | Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach' including administration groups as fixed effects, and baseline data as covariate. |
| Secondary | Percentage of Participants With Fall Events From Fall Questionnaire | Baseline through Week 14 | Participants evaluated their experience with and details of falls which were recorded. |
| Secondary | Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score | Baseline, Week 14 | The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates. |
| Secondary | Change From Baseline on the Patient Global Assessment Illness (PGAI) Score | Baseline, Week 14 | |
| Secondary | Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument | Baseline, Week 14 | The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate. |
| Secondary | Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score | Baseline, Week 14 | BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. 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. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score | Baseline, Week 14 | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement) | Baseline, 14 Weeks | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Clinical Global Impression of Severity (CGI-S) | Baseline, Week 14 | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) | Baseline, Week 14 | All participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score | Baseline, Week 14 | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Fall Events From Fall Questionnaire | Baseline through Week 14 | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score | Baseline, Week 14 | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Patient Global Assessment Illness (PGAI) Score | Baseline, Week 14 | Zero participants analyzed. PGAI outcome measure was registered incorrectly thus no analysis produced. | ||
| SECONDARY | Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument | Baseline, Week 14 | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score | Baseline, Week 14 | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score | Duloxetine | -2.57 | Standard Error 0.12 | units on a scale | |
| Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score | Placebo | -1.80 | Standard Error 0.12 | units on a scale | |
| Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement) | Duloxetine | 2.23 | Standard Error 0.09 | units on a scale | |
| Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement) | Placebo | 2.84 | Standard Error 0.09 | units on a scale | |
| Change From Baseline on the Clinical Global Impression of Severity (CGI-S) | Duloxetine | -1.71 | Standard Error 0.07 | units on a scale | |
| Change From Baseline on the Clinical Global Impression of Severity (CGI-S) | Placebo | -1.22 | Standard Error 0.07 | units on a scale | |
| Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) | Duloxetine | Physical Functioning | 12.62 | Standard Error 1.27 | units on a scale |
| Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) | Placebo | Physical Functioning | 6.23 | Standard Error 1.27 | units on a scale |
| Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) | Duloxetine | Role (Physical) | 11.44 | Standard Error 1.29 | units on a scale |
| Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) | Placebo | Role (Physical) | 3.66 | Standard Error 1.30 | units on a scale |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Duloxetine | 178 | |
| Overall Study | STARTED | Placebo | 176 | |
| Overall Study | Efficacy Population | Duloxetine | 177 | |
| Overall Study | Efficacy Population | Placebo | 176 | |
| Overall Study | COMPLETED | Duloxetine | 161 | |
| Overall Study | COMPLETED | Placebo | 162 | |
| Overall Study | NOT COMPLETED | Duloxetine | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events270
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 | Duloxetine | 1 | 178 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 176 | 0 |
| other | Ear congestion | Ear and labyrinth disorders | Duloxetine | 1 | 178 | 1 |
| other | Ear congestion | Ear and labyrinth disorders | Placebo | 0 | 176 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Duloxetine | 1 | 178 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 0 | 176 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Duloxetine | 2 | 178 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 2 | 176 | 2 |
| other | Vertigo positional | Ear and labyrinth disorders | Duloxetine | 1 | 178 | 1 |
| other | Vertigo positional | Ear and labyrinth disorders | Placebo | 0 | 176 | 0 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Duloxetine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Duloxetine | 120 | 178 |
| Total, other adverse events | Placebo | 98 | 176 |
| Total, serious adverse events | Duloxetine | 1 | 178 |
| Total, serious adverse events | Placebo | 1 | 176 |
Source ClinicalTrials.gov
Papers7
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/NCT02248480
GET https://conductscience.org/api/trials/v1/NCT02248480/results?page=2