Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 34 for:    "Osteoarthritis" | ( Map: Japan )

An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)

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: NCT02335346
Recruitment Status : Completed
First Posted : January 9, 2015
Results First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Intervention Drug: Duloxetine
Enrollment 93
Recruitment Details All participants were consecutive participants from F1J-JE-HMGX, NCT02248480. No new participants were enrolled.
Pre-assignment Details  
Arm/Group Title Duloxetine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 93
Received At Least 1 Dose of Study Drug 93
Completed 81
Not Completed 12
Reason Not Completed
Adverse Event             11
Withdrawal by Subject             1
Arm/Group Title Duloxetine
Hide Arm/Group Description Duloxetine 20 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.
Overall Number of Baseline Participants 93
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants
66.2  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
Female
67
  72.0%
Male
26
  28.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
93
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
American Indian or Alaska Native
0
   0.0%
Asian
93
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 93 participants
93
1.Primary Outcome
Title Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Baseline through Week 53
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: Percentage of participants
Drug-Related Adverse Event 51.6
Serious Adverse Event 7.5
2.Secondary Outcome
Title Patient Global Impression-Improvement (PGI-I) at 50 Weeks
Hide Description 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).
Time Frame Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.09  (0.94)
3.Secondary Outcome
Title Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50
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).
Time Frame Baseline, Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.19  (0.99)
4.Secondary Outcome
Title Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Hide Description 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.
Time Frame Baseline, Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
Worst Pain -4.29  (2.05)
Least Pain -2.16  (1.66)
Average Pain -3.33  (1.81)
Pain Right Now -2.94  (2.19)
General Activity -3.03  (2.22)
Mood -2.48  (2.25)
Walking Ability -3.11  (2.17)
Normal Work -3.10  (2.41)
Relationship People -1.43  (2.07)
Sleep -1.81  (2.35)
Enjoy of Life -1.92  (2.16)
Average of 7 items -2.41  (1.81)
5.Secondary Outcome
Title Change From Baseline to 50 Weeks 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 millimeter (mm)(extreme).
Time Frame Baseline, Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
-20.23  (15.05)
6.Secondary Outcome
Title Change From Baseline to 50 Weeks 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. 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).
Time Frame Baseline, Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Functioning 15.27  (20.82)
Role (Physical) 11.90  (21.20)
Bodily Pain 21.32  (21.15)
General Health 10.89  (17.20)
Vitality 9.61  (16.16)
Social Functioning 6.45  (19.12)
Role(Emotional) 8.78  (23.13)
Mental Health 4.89  (18.37)
7.Secondary Outcome
Title Change From Baseline to 50 Weeks 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.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.
Time Frame Baseline, Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.15  (0.16)
8.Secondary Outcome
Title Change From Baseline to 50 Weeks 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.
Time Frame Baseline, Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.14  (4.93)
9.Secondary Outcome
Title Percentage of Participants With Fall Events From Fall Questionnaire
Hide Description Participants reported the details of their falls. Percentage equals the number of participants with fall events / total in treatment group * 100.
Time Frame Baseline through Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine 20 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.
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: Percentage of Participants
23.7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine
Hide Arm/Group Description Duloxetine 20 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.
All-Cause Mortality
Duloxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine
Affected / at Risk (%) # Events
Total   7/93 (7.53%)    
Gastrointestinal disorders   
Intestinal obstruction  1  1/93 (1.08%)  1
Infections and infestations   
Enteritis infectious  1  1/93 (1.08%)  1
Injury, poisoning and procedural complications   
Femur fracture  1  1/93 (1.08%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  2/93 (2.15%)  2
Lumbar spinal stenosis  1  1/93 (1.08%)  1
Nervous system disorders   
Loss of consciousness  1  1/93 (1.08%)  1
Progressive supranuclear palsy  1  1/93 (1.08%)  1
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
Affected / at Risk (%) # Events
Total   85/93 (91.40%)    
Blood and lymphatic system disorders   
Anaemia  1  1/93 (1.08%)  1
Cardiac disorders   
Tachycardia  1  1/93 (1.08%)  1
Ear and labyrinth disorders   
Ear pain  1  1/93 (1.08%)  2
Vertigo positional  1  1/93 (1.08%)  1
Eye disorders   
Chalazion  1  1/93 (1.08%)  1
Dry eye  1  1/93 (1.08%)  1
Vitreous floaters  1  1/93 (1.08%)  1
Gastrointestinal disorders   
Abdominal pain upper  1  1/93 (1.08%)  2
Chronic gastritis  1  1/93 (1.08%)  1
Constipation  1  18/93 (19.35%)  20
Dental caries  1  1/93 (1.08%)  1
Diarrhoea  1  1/93 (1.08%)  1
Gastritis  1  1/93 (1.08%)  1
Gastrooesophageal reflux disease  1  1/93 (1.08%)  1
Gingival swelling  1  1/93 (1.08%)  1
Nausea  1  4/93 (4.30%)  5
Stomatitis  1  2/93 (2.15%)  2
Toothache  1  1/93 (1.08%)  1
Vomiting  1  1/93 (1.08%)  1
General disorders   
Malaise  1  2/93 (2.15%)  2
Peripheral swelling  1  2/93 (2.15%)  2
Thirst  1  11/93 (11.83%)  11
Hepatobiliary disorders   
Alcoholic liver disease  1  1/93 (1.08%)  1
Immune system disorders   
Seasonal allergy  1  1/93 (1.08%)  1
Infections and infestations   
Acute sinusitis  1  1/93 (1.08%)  1
Bronchitis  1  5/93 (5.38%)  6
Chronic sinusitis  1  1/93 (1.08%)  1
Cystitis  1  2/93 (2.15%)  3
Gastroenteritis  1  1/93 (1.08%)  1
Gingivitis  1  1/93 (1.08%)  1
Herpes simplex  1  1/93 (1.08%)  1
Herpes zoster  1  4/93 (4.30%)  4
Influenza  1  1/93 (1.08%)  1
Nasopharyngitis  1  15/93 (16.13%)  21
Onychomycosis  1  2/93 (2.15%)  2
Oral herpes  1  3/93 (3.23%)  3
Otitis media chronic  1  1/93 (1.08%)  1
Paronychia  1  1/93 (1.08%)  2
Pharyngitis  1  4/93 (4.30%)  4
Purulence  1  1/93 (1.08%)  1
Sinusitis  1  2/93 (2.15%)  2
Tinea pedis  1  1/93 (1.08%)  1
Upper respiratory tract infection  1  1/93 (1.08%)  1
Viral upper respiratory tract infection  1  1/93 (1.08%)  3
Injury, poisoning and procedural complications   
Animal bite  1  1/93 (1.08%)  1
Arthropod bite  1  1/93 (1.08%)  1
Bone contusion  1  1/93 (1.08%)  1
Cartilage injury  1  1/93 (1.08%)  1
Contusion  1  8/93 (8.60%)  11
Epicondylitis  1  2/93 (2.15%)  2
Excoriation  1  2/93 (2.15%)  2
Foot fracture  1  1/93 (1.08%)  1
Frostbite  1  1/93 (1.08%)  1
Heat illness  1  1/93 (1.08%)  1
Ligament sprain  1  6/93 (6.45%)  6
Muscle rupture  1  1/93 (1.08%)  1
Rib fracture  1  1/93 (1.08%)  1
Stab wound  1  1/93 (1.08%)  1
Thermal burn  1  1/93 (1.08%)  1
Wound  1  2/93 (2.15%)  2
Investigations   
Alanine aminotransferase increased  1  1/93 (1.08%)  1
Aspartate aminotransferase increased  1  1/93 (1.08%)  1
Blood creatine phosphokinase increased  1  1/93 (1.08%)  1
Blood lactate dehydrogenase increased  1  1/93 (1.08%)  1
Blood potassium increased  1  1/93 (1.08%)  1
Blood pressure increased  1  1/93 (1.08%)  1
Blood uric acid increased  1  1/93 (1.08%)  1
Blood urine present  1  2/93 (2.15%)  2
Glycosylated haemoglobin increased  1  2/93 (2.15%)  2
International normalised ratio increased  1  1/93 (1.08%)  1
Liver function test abnormal  1  1/93 (1.08%)  1
Protein urine present  1  1/93 (1.08%)  1
Urobilinogen urine increased  1  1/93 (1.08%)  1
Weight increased  1  1/93 (1.08%)  1
White blood cell count increased  1  1/93 (1.08%)  1
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/93 (1.08%)  1
Glucose tolerance impaired  1  1/93 (1.08%)  1
Hyperlipidaemia  1  1/93 (1.08%)  1
Obesity  1  2/93 (2.15%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/93 (1.08%)  1
Arthritis  1  2/93 (2.15%)  2
Back pain  1  5/93 (5.38%)  5
Bursitis  1  1/93 (1.08%)  1
Intervertebral disc degeneration  1  1/93 (1.08%)  2
Intervertebral disc protrusion  1  2/93 (2.15%)  2
Lumbar spinal stenosis  1  3/93 (3.23%)  3
Muscle spasms  1  4/93 (4.30%)  4
Musculoskeletal pain  1  1/93 (1.08%)  1
Myalgia  1  1/93 (1.08%)  1
Myofascitis  1  1/93 (1.08%)  1
Nodal osteoarthritis  1  2/93 (2.15%)  2
Osteoarthritis  1  2/93 (2.15%)  3
Osteoporosis  1  2/93 (2.15%)  2
Pain in extremity  1  1/93 (1.08%)  1
Periarthritis  1  2/93 (2.15%)  2
Spinal osteoarthritis  1  4/93 (4.30%)  5
Temporomandibular joint syndrome  1  1/93 (1.08%)  1
Tenosynovitis  1  1/93 (1.08%)  1
Tenosynovitis stenosans  1  1/93 (1.08%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma  1  1/93 (1.08%)  1
Nervous system disorders   
Carpal tunnel syndrome  1  1/93 (1.08%)  1
Cervical radiculopathy  1  1/93 (1.08%)  1
Dizziness  1  5/93 (5.38%)  5
Headache  1  2/93 (2.15%)  2
Hypoaesthesia  1  2/93 (2.15%)  2
Intercostal neuralgia  1  1/93 (1.08%)  1
Migraine  1  1/93 (1.08%)  1
Neuropathy peripheral  1  1/93 (1.08%)  1
Sciatica  1  3/93 (3.23%)  3
Somnolence  1  12/93 (12.90%)  12
Psychiatric disorders   
Disorientation  1  1/93 (1.08%)  1
Insomnia  1  2/93 (2.15%)  2
Neurosis  1  1/93 (1.08%)  1
Renal and urinary disorders   
Dysuria  1  1/93 (1.08%)  1
Hypertonic bladder  1  1/93 (1.08%)  1
Pollakiuria  1  2/93 (2.15%)  2
Renal impairment  1  1/93 (1.08%)  2
Stress urinary incontinence  1  1/93 (1.08%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  4/93 (4.30%)  6
Cough  1  5/93 (5.38%)  5
Oropharyngeal pain  1  1/93 (1.08%)  1
Rhinitis allergic  1  2/93 (2.15%)  2
Upper respiratory tract inflammation  1  4/93 (4.30%)  4
Skin and subcutaneous tissue disorders   
Eczema  1  3/93 (3.23%)  3
Erythema  1  2/93 (2.15%)  2
Haemorrhage subcutaneous  1  2/93 (2.15%)  2
Hyperhidrosis  1  2/93 (2.15%)  2
Hyperkeratosis  1  1/93 (1.08%)  2
Pruritus  1  3/93 (3.23%)  3
Seborrhoeic dermatitis  1  1/93 (1.08%)  1
Solar dermatitis  1  1/93 (1.08%)  1
Yellow skin  1  1/93 (1.08%)  1
Vascular disorders   
Hypertension  1  7/93 (7.53%)  7
Lymphoedema  1  1/93 (1.08%)  1
Orthostatic hypotension  1  1/93 (1.08%)  1
Peripheral arterial occlusive disease  1  1/93 (1.08%)  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: NCT02335346     History of Changes
Other Study ID Numbers: 15611
F1J-JE-HMHD ( Other Identifier: Eli Lilly and Company )
First Submitted: January 7, 2015
First Posted: January 9, 2015
Results First Submitted: April 21, 2017
Results First Posted: November 7, 2017
Last Update Posted: November 7, 2017