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Trial record 3 of 34 for:    "Osteoarthritis" | ( Map: Japan )

A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02248480
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 354
Recruitment Details  
Pre-assignment Details All started participants (pt) were randomized and received at least one dose of study drug. Efficacy population had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days. Placebo administered orally once a day for 15 weeks.
Period Title: Overall Study
Started 178 176
Efficacy Population 177 176
Completed 161 162
Not Completed 17 14
Reason Not Completed
Lack of Efficacy             4             6
Adverse Event             11             2
Withdrawal by Subject             2             4
Entry Criteria Not Met             0             1
Other:Physician Decision             0             1
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days. Placebo administered orally once a day for 15 weeks. Total of all reporting groups
Overall Number of Baseline Participants 177 176 353
Hide Baseline Analysis Population Description
Al randomized participants who received at least 1 dose of study drug and had 1 post-dose efficacy assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 177 participants 176 participants 353 participants
65.5  (8.0) 66.4  (8.4) 65.9  (8.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 176 participants 353 participants
Female
142
  80.2%
132
  75.0%
274
  77.6%
Male
35
  19.8%
44
  25.0%
79
  22.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 176 participants 353 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
177
 100.0%
176
 100.0%
353
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 177 participants 176 participants 353 participants
177 176 353
1.Primary Outcome
Title Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score
Hide Description 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.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.57  (0.12) -1.80  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)
Hide Description 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.
Time Frame Baseline, 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.23  (0.09) 2.84  (0.09)
3.Secondary Outcome
Title Change From Baseline on the Clinical Global Impression of Severity (CGI-S)
Hide Description 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.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.71  (0.07) -1.22  (0.07)
4.Secondary Outcome
Title Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)
Hide Description 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.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Functioning 12.62  (1.27) 6.23  (1.27)
Role (Physical) 11.44  (1.29) 3.66  (1.30)
Bodily Pain 16.32  (1.22) 9.63  (1.22)
General Health 5.58  (0.93) 1.82  (0.94)
Vitality 3.99  (1.04) 3.16  (1.04)
Social Functioning 5.66  (1.14) 2.54  (1.15)
Role (Emotional) 6.32  (1.27) 0.70  (1.28)
Mental Health 3.02  (0.99) 1.48  (0.99)
5.Secondary Outcome
Title Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score
Hide Description 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.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.78  (0.23) -0.51  (0.24)
6.Secondary Outcome
Title Percentage of Participants With Fall Events From Fall Questionnaire
Hide Description Participants evaluated their experience with and details of falls which were recorded.
Time Frame Baseline through Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 178 176
Measure Type: Number
Unit of Measure: percentage of participants
10.1 9.7
7.Secondary Outcome
Title Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score
Hide Description 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.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-17.41  (0.91) -10.45  (0.91)
8.Secondary Outcome
Title Change From Baseline on the Patient Global Assessment Illness (PGAI) Score
Hide Description [Not Specified]
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. PGAI outcome measure was registered incorrectly thus no analysis produced.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.

Duloxetine: Administered orally

Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument
Hide Description 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.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.12  (0.01) 0.07  (0.01)
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worse Pain -2.92  (0.15) -2.13  (0.15)
Least Pain -1.61  (0.11) -1.05  (0.11)
Pain Right Now -2.29  (0.13) -1.52  (0.13)
General Activity -2.42  (0.14) -1.52  (0.14)
Walking Ability -2.58  (0.14) -1.74  (0.14)
Mood -1.95  (0.12) -1.43  (0.12)
Normal Work -2.48  (0.13) -1.67  (0.13)
Relationship to People -1.23  (0.11) -0.81  (0.11)
Sleep -1.65  (0.11) -1.19  (0.11)
Enjoyment of Life -1.78  (0.12) -1.16  (0.12)
Average of 7 Items -2.01  (0.11) -1.34  (0.11)
11.Secondary Outcome
Title Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale
Hide Description 24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.
Time Frame Baseline,Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Measure Type: Number
Unit of Measure: percentage of participants
>=30% 72.3 52.8
>=50% 55.4 38.6
12.Secondary Outcome
Title Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score
Hide Description 24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. 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.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Average Pain -2.45  (0.12) -1.79  (0.12)
Worst Pain -2.73  (0.14) -1.97  (0.14)
13.Secondary Outcome
Title Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score
Hide Description 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).
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Measure Type: Number
Unit of Measure: percentage of participants
>=30% 72.3 52.8
>=50% 55.4 38.6
14.Secondary Outcome
Title Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria
Hide Description A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Measure Type: Number
Unit of Measure: percentage of participants
83.6 61.9
15.Secondary Outcome
Title Change From Baseline on the WOMAC Questionnaire Pain Subscale
Hide Description The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (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, baseline data as covariates.
Time Frame Baseline, 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.99  (0.21) -2.43  (0.21)
16.Secondary Outcome
Title Change From Baseline on the WOMAC Questionnaire Stiffness Subscale
Hide Description The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (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, baseline data as covariates.
Time Frame Baseline, 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.66  (0.09) -0.98  (0.09)
17.Secondary Outcome
Title Change From Baseline on the WOMAC Questionnaire Physical Function Subscale
Hide Description The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (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, baseline data as covariates.
Time Frame Baseline, 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Placebo administered orally once a day for 15 weeks.
Overall Number of Participants Analyzed 177 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-11.77  (0.67) -7.07  (0.66)
Time Frame [Not Specified]
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days. Placebo administered orally once a day for 15 weeks.
All-Cause Mortality
Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/178 (0.56%)      1/176 (0.57%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cerebellar tumour  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Malignant ascites  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   120/178 (67.42%)      98/176 (55.68%)    
Cardiac disorders     
Palpitations  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Ear and labyrinth disorders     
Ear congestion  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Tinnitus  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Vertigo  1  2/178 (1.12%)  2 2/176 (1.14%)  2
Vertigo positional  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Endocrine disorders     
Basedow's disease  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Eye disorders     
Blepharitis  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Dry eye  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Vision blurred  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  2/178 (1.12%)  2 4/176 (2.27%)  4
Abdominal distension  1  2/178 (1.12%)  2 1/176 (0.57%)  1
Abdominal pain upper  1  2/178 (1.12%)  2 1/176 (0.57%)  1
Anal fissure  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Cheilitis  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Colitis ischaemic  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Constipation  1  19/178 (10.67%)  20 3/176 (1.70%)  3
Dental caries  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Diarrhoea  1  6/178 (3.37%)  7 1/176 (0.57%)  1
Dyspepsia  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Faeces hard  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Gastritis  1  3/178 (1.69%)  3 1/176 (0.57%)  1
Gastrooesophageal reflux disease  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Glossitis  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Nausea  1  18/178 (10.11%)  21 1/176 (0.57%)  1
Stomatitis  1  3/178 (1.69%)  3 1/176 (0.57%)  1
Vomiting  1  3/178 (1.69%)  4 0/176 (0.00%)  0
General disorders     
Asthenia  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Feeling abnormal  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Malaise  1  12/178 (6.74%)  12 2/176 (1.14%)  2
Peripheral swelling  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Thirst  1  19/178 (10.67%)  19 3/176 (1.70%)  3
Hepatobiliary disorders     
Hepatic function abnormal  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Infections and infestations     
Bronchitis  1  0/178 (0.00%)  0 3/176 (1.70%)  3
Conjunctivitis  1  1/178 (0.56%)  1 1/176 (0.57%)  1
Cystitis  1  0/178 (0.00%)  0 2/176 (1.14%)  3
Gastroenteritis  1  2/178 (1.12%)  2 2/176 (1.14%)  2
Gastroenteritis rotavirus  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Gingival abscess  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Gingivitis  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Herpes zoster  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Hordeolum  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Influenza  1  1/178 (0.56%)  1 2/176 (1.14%)  2
Nasopharyngitis  1  27/178 (15.17%)  27 28/176 (15.91%)  30
Oral herpes  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Paronychia  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Periodontitis  1  1/178 (0.56%)  1 1/176 (0.57%)  1
Pharyngitis  1  1/178 (0.56%)  1 1/176 (0.57%)  1
Tonsillitis  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Injury, poisoning and procedural complications     
Chillblains  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Comminuted fracture  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Contusion  1  9/178 (5.06%)  10 7/176 (3.98%)  7
Excoriation  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Frostbite  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Ligament sprain  1  2/178 (1.12%)  2 1/176 (0.57%)  1
Limb crushing injury  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Muscle injury  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Muscle rupture  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Patella fracture  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Procedural pain  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Thermal burn  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Investigations     
Alanine aminotransferase increased  1  8/178 (4.49%)  8 1/176 (0.57%)  1
Aspartate aminotransferase increased  1  7/178 (3.93%)  7 1/176 (0.57%)  1
Blood creatine phosphokinase increased  1  1/178 (0.56%)  1 1/176 (0.57%)  1
Blood creatinine increased  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Blood potassium decreased  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Blood potassium increased  1  0/178 (0.00%)  0 2/176 (1.14%)  2
Blood uric acid increased  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Blood urine present  1  3/178 (1.69%)  3 1/176 (0.57%)  1
Gamma-glutamyltransferase increased  1  0/178 (0.00%)  0 3/176 (1.70%)  3
Liver function test abnormal  1  1/178 (0.56%)  1 0/176 (0.00%)  0
White blood cell count increased  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  9/178 (5.06%)  9 1/176 (0.57%)  1
Diabetes mellitus  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/178 (1.12%)  2 3/176 (1.70%)  4
Back pain  1  1/178 (0.56%)  1 8/176 (4.55%)  10
Costochondritis  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Intervertebral disc protrusion  1  2/178 (1.12%)  2 0/176 (0.00%)  0
Limb discomfort  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Lumbar spinal stenosis  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Muscle spasms  1  2/178 (1.12%)  2 0/176 (0.00%)  0
Myalgia  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Myalgia intercostal  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Nodal osteoarthritis  1  0/178 (0.00%)  0 2/176 (1.14%)  2
Osteoarthritis  1  1/178 (0.56%)  1 2/176 (1.14%)  2
Osteoporosis  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Pain in extremity  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Periarthritis  1  1/178 (0.56%)  1 1/176 (0.57%)  1
Rotator cuff syndrome  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Spinal osteoarthritis  1  1/178 (0.56%)  1 3/176 (1.70%)  3
Synovitis  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Tenosynovitis  1  1/178 (0.56%)  1 1/176 (0.57%)  1
Tenosynovitis stenosans  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Nervous system disorders     
Carpal tunnel syndrome  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Cerebral infarction  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Cervicobrachial syndrome  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Dizziness  1  2/178 (1.12%)  3 2/176 (1.14%)  2
Dizziness postural  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Dysgeusia  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Headache  1  1/178 (0.56%)  1 5/176 (2.84%)  11
Hypoaesthesia  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Loss of consciousness  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Migraine  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Sciatica  1  1/178 (0.56%)  1 3/176 (1.70%)  3
Somnolence  1  24/178 (13.48%)  24 6/176 (3.41%)  6
Psychiatric disorders     
Abulia  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Depression  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Insomnia  1  3/178 (1.69%)  3 0/176 (0.00%)  0
Renal and urinary disorders     
Dysuria  1  2/178 (1.12%)  2 0/176 (0.00%)  0
Hypertonic bladder  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Pollakiuria  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Stress urinary incontinence  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Urethral haemorrhage  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Urinary incontinence  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Urine flow decreased  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/178 (0.56%)  1 1/176 (0.57%)  1
Cough  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Rhinitis allergic  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Upper respiratory tract inflammation  1  3/178 (1.69%)  5 1/176 (0.57%)  2
Skin and subcutaneous tissue disorders     
Dermatitis  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Dermatitis contact  1  2/178 (1.12%)  2 0/176 (0.00%)  0
Eczema  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Eczema asteatotic  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Haemorrhage subcutaneous  1  1/178 (0.56%)  1 2/176 (1.14%)  2
Hyperkeratosis  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Ingrowing nail  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Prurigo  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Seborrhoeic dermatitis  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Vascular disorders     
Hot flush  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Hypertension  1  1/178 (0.56%)  1 0/176 (0.00%)  0
Orthostatic hypotension  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Peripheral arterial occlusive disease  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Varicose vein  1  0/178 (0.00%)  0 1/176 (0.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02248480     History of Changes
Other Study ID Numbers: 14375
F1J-JE-HMGX ( Other Identifier: Eli Lilly and Company )
First Submitted: September 22, 2014
First Posted: September 25, 2014
Results First Submitted: June 15, 2016
Results First Posted: January 16, 2017
Last Update Posted: January 16, 2017