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An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)

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ClinicalTrials.gov Identifier: NCT01621191
Recruitment Status : Completed
First Posted : June 18, 2012
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
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 Fibromyalgia
Intervention Drug: Duloxetine
Enrollment 149

Recruitment Details Participants who completed the 15-week treatment in the preceding study F1J-JE-HMGZ (HMGZ) (NCT01552057) were enrolled in this study.
Pre-assignment Details Enrolled participants who completed the 50-week treatment period were considered to have completed the study. After study completion or early discontinuation, participants completed a 2-week taper and were observed 1 week post-treatment for safety.
Arm/Group Title Duloxetine 60 mg
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Treatment Period: Up to a 60-milligram (mg) dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).

During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.

Period Title: Overall Study
Started 149
Received at Least 1 Dose of Study Drug 149
Had at Least 1 Post-Baseline Observation 148
Completed 124
Not Completed 25
Reason Not Completed
Adverse Event             9
Withdrawal by Subject             8
Lack of Efficacy             6
Lost to Follow-up             1
Site Removed From Study             1
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description

Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).

During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.

Overall Number of Baseline Participants 148
Hide Baseline Analysis Population Description
Enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline observation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants
47.3  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants
Female
121
  81.8%
Male
27
  18.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 148 participants
148
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 148 participants
148
1.Primary Outcome
Title Number of Participants Who Experienced an Adverse Event (AE)
Hide Description A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Time Frame Baseline through 53 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description:

Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).

During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.

Overall Number of Participants Analyzed 149
Measure Type: Number
Unit of Measure: participants
138
2.Secondary Outcome
Title Patient Global Impression-Improvement (PGI-I) at Endpoint
Hide Description PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse).
Time Frame 50 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received at least 1 dose of study drug and had a Week 50 PGI-I assessment.
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description:
Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.48  (1.31)
3.Secondary Outcome
Title Clinical Global Impression-Improvement (CGI-I) at Endpoint
Hide Description CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse).
Time Frame 50 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received at least 1 dose of study drug and had a Week 50 CGI-I assessment.
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description:
Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.34  (1.08)
4.Secondary Outcome
Title Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)
Hide Description FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact.
Time Frame Baseline, 50 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received at least 1 dose of study drug and had a Week 50 FIQ assessment.
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description:
Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.00  (15.12)
5.Secondary Outcome
Title Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Hide Description BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items.
Time Frame Baseline, 50 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received at least 1 dose of study drug and had a Week 50 BPI-S or BPI-W assessment.
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description:
Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
Average Pain -1.31  (1.70)
Worst Pain -1.53  (1.87)
Least Pain -1.26  (1.82)
Pain Right Now -1.47  (2.03)
Interference With General Activity -0.72  (2.04)
Interference With Mood -0.82  (1.82)
Interference With Walking Ability -0.73  (2.04)
Interference With Normal Work -0.66  (2.01)
Interference With Relations With Other People -0.38  (1.95)
Interference With Sleep -1.00  (2.26)
Interference With Enjoyment of Life -0.68  (2.00)
Average Interference -0.71  (1.65)
6.Secondary Outcome
Title Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Hide Description The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Time Frame Baseline, 50 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received at least 1 dose of study drug and had a Week 50 SF-36 assessment.
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description:
Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Functioning 4.26  (14.54)
Role-Physical 4.02  (17.05)
Bodily Pain 6.89  (14.89)
General Health 4.14  (11.88)
Vitality 0.16  (18.13)
Social Functioning 3.26  (21.47)
Role-Emotional 3.55  (18.83)
Mental Health 2.13  (14.00)
7.Secondary Outcome
Title Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)
Hide Description The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms.
Time Frame Baseline, 50 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received at least 1 dose of study drug and had a Week 50 BDI-II assessment.
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description:
Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.94  (5.22)
8.Secondary Outcome
Title Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010
Hide Description WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12.
Time Frame Baseline, 50 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received at least 1 dose of study drug and had a Week 50 WPI or SS assessment.
Arm/Group Title Duloxetine 60 mg
Hide Arm/Group Description:
Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
WPI -1.46  (3.74)
SS -0.37  (1.27)
Time Frame Baseline through 53 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 60 mg Duloxetine
Hide Arm/Group Description

Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).

During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.

All-Cause Mortality
60 mg Duloxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
60 mg Duloxetine
Affected / at Risk (%) # Events
Total   8/149 (5.37%)    
Eye disorders   
Retinal detachment  1  1/149 (0.67%)  1
Gastrointestinal disorders   
Subileus  1  1/149 (0.67%)  1
Injury, poisoning and procedural complications   
Clavicle fracture  1  1/149 (0.67%)  1
Rib fracture  1  1/149 (0.67%)  1
Skull fracture  1  1/149 (0.67%)  1
Thoracic vertebral fracture  1  1/149 (0.67%)  1
Traumatic intracranial haemorrhage  1  1/149 (0.67%)  1
Wound  1  1/149 (0.67%)  1
Metabolism and nutrition disorders   
Diabetes mellitus inadequate control  1  1/149 (0.67%)  1
Musculoskeletal and connective tissue disorders   
Spinal osteoarthritis  1  1/149 (0.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Rectal cancer  1  1/149 (0.67%)  1
Psychiatric disorders   
Schizoaffective disorder  1  1/149 (0.67%)  1
Self injurious behaviour  1  1/149 (0.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
60 mg Duloxetine
Affected / at Risk (%) # Events
Total   138/149 (92.62%)    
Blood and lymphatic system disorders   
Anaemia  1  2/149 (1.34%)  3
Cardiac disorders   
Bundle branch block left  1  1/149 (0.67%)  1
Bundle branch block right  1  1/149 (0.67%)  1
Palpitations  1  4/149 (2.68%)  4
Prinzmetal angina  1  1/149 (0.67%)  1
Sinus tachycardia  1  1/149 (0.67%)  1
Ear and labyrinth disorders   
Meniere's disease  1  1/149 (0.67%)  2
Tinnitus  1  3/149 (2.01%)  3
Vertigo  1  9/149 (6.04%)  9
Eye disorders   
Blepharitis allergic  1  1/149 (0.67%)  1
Cataract  1  1/149 (0.67%)  1
Conjunctival haemorrhage  1  2/149 (1.34%)  2
Conjunctivitis allergic  1  2/149 (1.34%)  2
Corneal degeneration  1  1/149 (0.67%)  1
Diplopia  1  1/149 (0.67%)  1
Dry eye  1  2/149 (1.34%)  2
Glaucoma  1  1/149 (0.67%)  1
Scleral haemorrhage  1  1/149 (0.67%)  1
Uveitis  1  1/149 (0.67%)  1
Vitreous floaters  1  1/149 (0.67%)  1
Vitreous haemorrhage  1  1/149 (0.67%)  1
Gastrointestinal disorders   
Abdominal discomfort  1  5/149 (3.36%)  7
Abdominal distension  1  3/149 (2.01%)  3
Abdominal pain  1  2/149 (1.34%)  2
Abdominal pain upper  1  8/149 (5.37%)  9
Constipation  1  27/149 (18.12%)  31
Dental caries  1  5/149 (3.36%)  5
Diarrhoea  1  3/149 (2.01%)  3
Dyspepsia  1  1/149 (0.67%)  1
Faeces hard  1  1/149 (0.67%)  1
Food poisoning  1  1/149 (0.67%)  1
Gastric ulcer  1  1/149 (0.67%)  1
Gastritis  1  4/149 (2.68%)  5
Gastrointestinal motility disorder  1  1/149 (0.67%)  1
Gastrooesophageal reflux disease  1  3/149 (2.01%)  3
Haemorrhoids  1  1/149 (0.67%)  1
Irritable bowel syndrome  1  3/149 (2.01%)  3
Large intestine polyp  1  2/149 (1.34%)  2
Nausea  1  22/149 (14.77%)  24
Periodontal disease  1  3/149 (2.01%)  3
Sensitivity of teeth  1  1/149 (0.67%)  1
Stomatitis  1  4/149 (2.68%)  4
Toothache  1  1/149 (0.67%)  1
Vomiting  1  4/149 (2.68%)  5
General disorders   
Asthenia  1  1/149 (0.67%)  1
Drug withdrawal syndrome  1  5/149 (3.36%)  5
Fatigue  1  2/149 (1.34%)  2
Feeling abnormal  1  4/149 (2.68%)  4
Local swelling  1  2/149 (1.34%)  2
Malaise  1  8/149 (5.37%)  8
Oedema  1  3/149 (2.01%)  3
Oedema peripheral  1  1/149 (0.67%)  1
Pyrexia  1  2/149 (1.34%)  2
Submandibular mass  1  1/149 (0.67%)  1
Thirst  1  11/149 (7.38%)  11
Hepatobiliary disorders   
Cholelithiasis  1  1/149 (0.67%)  1
Hepatic function abnormal  1  1/149 (0.67%)  1
Immune system disorders   
Drug hypersensitivity  1  1/149 (0.67%)  1
Seasonal allergy  1  9/149 (6.04%)  10
Infections and infestations   
Body tinea  1  2/149 (1.34%)  2
Bronchitis  1  4/149 (2.68%)  4
Cystitis  1  6/149 (4.03%)  6
Gastroenteritis  1  3/149 (2.01%)  4
Gastroenteritis viral  1  3/149 (2.01%)  3
Gingivitis  1  2/149 (1.34%)  2
Herpes zoster  1  2/149 (1.34%)  2
Hordeolum  1  2/149 (1.34%)  3
Infected dermal cyst  1  1/149 (0.67%)  1
Influenza  1  6/149 (4.03%)  6
Nasopharyngitis  1  58/149 (38.93%)  102
Oral candidiasis  1  1/149 (0.67%)  1
Oral herpes  1  5/149 (3.36%)  6
Paronychia  1  4/149 (2.68%)  5
Periodontitis  1  1/149 (0.67%)  1
Peritonitis  1  1/149 (0.67%)  1
Pertussis  1  1/149 (0.67%)  1
Pharyngitis  1  5/149 (3.36%)  5
Pulpitis dental  1  1/149 (0.67%)  1
Pyelonephritis  1  1/149 (0.67%)  1
Rhinitis  1  3/149 (2.01%)  3
Subcutaneous abscess  1  1/149 (0.67%)  2
Tinea infection  1  1/149 (0.67%)  1
Tonsillitis  1  1/149 (0.67%)  1
Upper respiratory tract infection  1  4/149 (2.68%)  7
Injury, poisoning and procedural complications   
Arthropod sting  1  2/149 (1.34%)  2
Cartilage injury  1  1/149 (0.67%)  1
Chillblains  1  2/149 (1.34%)  2
Contusion  1  6/149 (4.03%)  8
Fall  1  1/149 (0.67%)  1
Ligament sprain  1  5/149 (3.36%)  6
Limb injury  1  1/149 (0.67%)  1
Patella fracture  1  1/149 (0.67%)  1
Post-traumatic neck syndrome  1  1/149 (0.67%)  1
Scratch  1  2/149 (1.34%)  2
Tooth fracture  1  1/149 (0.67%)  1
Tooth injury  1  1/149 (0.67%)  1
Wound  1  1/149 (0.67%)  1
Investigations   
Alanine aminotransferase increased  1  1/149 (0.67%)  1
Blood bilirubin increased  1  3/149 (2.01%)  6
Blood cholesterol increased  1  1/149 (0.67%)  2
Blood creatine phosphokinase increased  1  1/149 (0.67%)  1
Blood glucose increased  1  1/149 (0.67%)  1
Blood triglycerides increased  1  4/149 (2.68%)  5
Blood uric acid increased  1  2/149 (1.34%)  2
Eosinophil count increased  1  2/149 (1.34%)  2
Gamma-glutamyltransferase increased  1  7/149 (4.70%)  8
Haematocrit decreased  1  1/149 (0.67%)  1
Haemoglobin decreased  1  1/149 (0.67%)  1
Protein total decreased  1  2/149 (1.34%)  2
Weight decreased  1  2/149 (1.34%)  2
Weight increased  1  14/149 (9.40%)  14
White blood cell count decreased  1  1/149 (0.67%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  3/149 (2.01%)  3
Dehydration  1  1/149 (0.67%)  1
Diabetes mellitus  1  1/149 (0.67%)  1
Dyslipidaemia  1  2/149 (1.34%)  2
Increased appetite  1  1/149 (0.67%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/149 (2.68%)  4
Back pain  1  10/149 (6.71%)  11
Lumbar spinal stenosis  1  1/149 (0.67%)  1
Muscle spasms  1  1/149 (0.67%)  1
Musculoskeletal pain  1  1/149 (0.67%)  1
Musculoskeletal stiffness  1  3/149 (2.01%)  3
Myofascitis  1  1/149 (0.67%)  1
Neck mass  1  1/149 (0.67%)  1
Neck pain  1  1/149 (0.67%)  1
Osteoarthritis  1  2/149 (1.34%)  3
Pain in extremity  1  2/149 (1.34%)  2
Periarthritis  1  4/149 (2.68%)  4
Rotator cuff syndrome  1  1/149 (0.67%)  1
Spinal column stenosis  1  1/149 (0.67%)  1
Spinal osteoarthritis  1  1/149 (0.67%)  1
Synovial cyst  1  2/149 (1.34%)  2
Temporomandibular joint syndrome  1  1/149 (0.67%)  1
Tenosynovitis  1  2/149 (1.34%)  2
Nervous system disorders   
Autonomic neuropathy  1  1/149 (0.67%)  1
Cubital tunnel syndrome  1  1/149 (0.67%)  1
Dizziness  1  9/149 (6.04%)  10
Dysgeusia  1  2/149 (1.34%)  2
Head discomfort  1  1/149 (0.67%)  1
Headache  1  8/149 (5.37%)  9
Hypoaesthesia  1  2/149 (1.34%)  2
Loss of consciousness  1  1/149 (0.67%)  1
Parosmia  1  1/149 (0.67%)  1
Poor quality sleep  1  1/149 (0.67%)  1
Radial nerve palsy  1  1/149 (0.67%)  1
Sciatica  1  1/149 (0.67%)  1
Sedation  1  1/149 (0.67%)  1
Somnolence  1  34/149 (22.82%)  34
Visual field defect  1  1/149 (0.67%)  1
Psychiatric disorders   
Anxiety  1  1/149 (0.67%)  1
Delirium  1  1/149 (0.67%)  1
Insomnia  1  9/149 (6.04%)  9
Nightmare  1  3/149 (2.01%)  3
Somatoform disorder gastrointestinal  1  1/149 (0.67%)  1
Renal and urinary disorders   
Dysuria  1  1/149 (0.67%)  1
Pollakiuria  1  1/149 (0.67%)  1
Reproductive system and breast disorders   
Dysmenorrhoea  1  1/122 (0.82%)  1
Menopausal symptoms  1  1/122 (0.82%)  2
Respiratory, thoracic and mediastinal disorders   
Asthma  1  5/149 (3.36%)  6
Cough  1  2/149 (1.34%)  2
Dyspnoea  1  1/149 (0.67%)  1
Oropharyngeal pain  1  4/149 (2.68%)  5
Rhinitis allergic  1  5/149 (3.36%)  5
Rhinorrhoea  1  1/149 (0.67%)  1
Upper respiratory tract inflammation  1  2/149 (1.34%)  2
Skin and subcutaneous tissue disorders   
Alopecia areata  1  1/149 (0.67%)  1
Dermatitis  1  2/149 (1.34%)  3
Dermatitis allergic  1  1/149 (0.67%)  1
Dermatitis contact  1  2/149 (1.34%)  2
Eczema  1  5/149 (3.36%)  5
Erythema  1  2/149 (1.34%)  2
Haemorrhage subcutaneous  1  3/149 (2.01%)  3
Hyperhidrosis  1  1/149 (0.67%)  1
Miliaria  1  7/149 (4.70%)  7
Pityriasis rosea  1  1/149 (0.67%)  1
Prurigo  1  1/149 (0.67%)  1
Pruritus  1  3/149 (2.01%)  3
Purpura  1  1/149 (0.67%)  1
Pustular psoriasis  1  1/149 (0.67%)  1
Rash  1  1/149 (0.67%)  1
Urticaria  1  4/149 (2.68%)  4
Vascular disorders   
Hypertension  1  6/149 (4.03%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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: NCT01621191     History of Changes
Other Study ID Numbers: 14614
F1J-JE-HMHB ( Other Identifier: Eli Lilly and Company )
First Submitted: June 14, 2012
First Posted: June 18, 2012
Results First Submitted: January 27, 2015
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015