An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)
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|ClinicalTrials.gov Identifier: NCT02335346|
Recruitment Status : Completed
First Posted : January 9, 2015
Results First Posted : November 7, 2017
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Knee||Drug: Duloxetine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Extension Study of Phase 3 Trial of Duloxetine in Patients With Osteoarthritis and Knee Pain|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
- Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) [ Time Frame: 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.
- Patient Global Impression-Improvement (PGI-I) at 50 Weeks [ Time Frame: 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).
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50 [ Time Frame: 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).
- Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) [ Time Frame: 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.
- Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score [ Time Frame: 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).
- Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 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).
- Change From Baseline to 50 Weeks on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument [ Time Frame: 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.
- Change From Baseline to 50 Weeks on the Beck Depression Inventory (BDI-II) Total Score [ Time Frame: 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.
- Percentage of Participants With Fall Events From Fall Questionnaire [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335346
|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.|
|Kobe, Japan, 650-0046|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|