Trial · NCT02335346
An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)
NCT02335346, Phase 3, Completed, Eli Lilly and Company; results first posted 2017-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480). Trials, record NCT02335346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02335346
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)
- NCT number
- NCT02335346
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 93 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Duloxetine
- First posted
- 2015-01-09
- Last updated
- 2019-09-18
- Results first posted
- 2017-11-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) | Baseline through Week 53 | A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy. |
| Secondary | Patient Global Impression-Improvement (PGI-I) at 50 Weeks | Week 50 | Patient 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). |
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50 | Baseline, Week 50 | 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). |
| Secondary | Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Baseline, Week 50 | Brief Pain Inventory Severity and Interference Scores: 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. |
| Secondary | Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score | Baseline, Week 50 | 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 millimeter (mm)(extreme). |
| Secondary | Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36) | Baseline, Week 50 | 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. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-6); social functioning (range: 2-10); bodily pain (range: 2-11); vitality (range: 4-24); mental health (range: 5-30). |
| Secondary | Change From Baseline to 50 Weeks on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument | Baseline, Week 50 | The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument.The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression 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 with scores ranging from -0.111 to 1.0. A higher score indicates better health state. |
| Secondary | Change From Baseline to 50 Weeks on the Beck Depression Inventory (BDI-II) Total Score | Baseline, Week 50 | 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. |
| Secondary | Percentage of Participants With Fall Events From Fall Questionnaire | Baseline through Week 50 | Participants reported the details of their falls. Percentage equals the number of participants with fall events / total in treatment group \* 100. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) | Baseline through Week 53 | All enrolled participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Patient Global Impression-Improvement (PGI-I) at 50 Weeks | Week 50 | All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50 | Baseline, Week 50 | All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Baseline, Week 50 | All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score | Baseline, Week 50 | All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36) | Baseline, Week 50 | All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 50 Weeks on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument | Baseline, Week 50 | All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 50 Weeks on the Beck Depression Inventory (BDI-II) Total Score | Baseline, Week 50 | All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Fall Events From Fall Questionnaire | Baseline through Week 50 | All enrolled participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) | Duloxetine | Drug-Related Adverse Event | 51.6 | Percentage of participants | |
| Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) | Duloxetine | Serious Adverse Event | 7.5 | Percentage of participants | |
| Patient Global Impression-Improvement (PGI-I) at 50 Weeks | Duloxetine | 2.09 | Standard Deviation 0.94 | units on a scale | |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50 | Duloxetine | -2.19 | Standard Deviation 0.99 | units on a scale | |
| Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Duloxetine | Worst Pain | -4.29 | Standard Deviation 2.05 | units on a scale |
| Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Duloxetine | Least Pain | -2.16 | Standard Deviation 1.66 | units on a scale |
| Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Duloxetine | Average Pain | -3.33 | Standard Deviation 1.81 | units on a scale |
| Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Duloxetine | Pain Right Now | -2.94 | Standard Deviation 2.19 | units on a scale |
| Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Duloxetine | General Activity | -3.03 | Standard Deviation 2.22 | units on a scale |
| Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Duloxetine | Mood | -2.48 | Standard Deviation 2.25 | units on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Duloxetine | 93 | |
| Overall Study | Received At Least 1 Dose of Study Drug | Duloxetine | 93 | |
| Overall Study | COMPLETED | Duloxetine | 81 | |
| Overall Study | NOT COMPLETED | Duloxetine | 12 |
Source ClinicalTrials.gov
Adverse events144
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 | Anaemia | Blood and lymphatic system disorders | Duloxetine | 1 | 93 | 1 |
| other | Tachycardia | Cardiac disorders | Duloxetine | 1 | 93 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Duloxetine | 1 | 93 | 2 |
| other | Vertigo positional | Ear and labyrinth disorders | Duloxetine | 1 | 93 | 1 |
| other | Chalazion | Eye disorders | Duloxetine | 1 | 93 | 1 |
| other | Dry eye | Eye disorders | Duloxetine | 1 | 93 | 1 |
| other | Vitreous floaters | Eye disorders | Duloxetine | 1 | 93 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Duloxetine | 1 | 93 | 2 |
| other | Chronic gastritis | Gastrointestinal disorders | Duloxetine | 1 | 93 | 1 |
| other | Constipation | Gastrointestinal disorders | Duloxetine | 18 | 93 | 20 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Duloxetine | ||
| Total, other adverse events | Duloxetine | 85 | 93 |
| Total, serious adverse events | Duloxetine | 7 | 93 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02335346
GET https://conductscience.org/api/trials/v1/NCT02335346/results?page=2