A Study of Duloxetine in Fibromyalgia
This study is currently recruiting participants.
Verified June 2013 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01552057
First received: March 9, 2012
Last updated: June 6, 2013
Last verified: June 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: Duloxetine 60 mg Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III Clinical Trial of Duloxetine in Participants With Fibromyalgia |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change From Baseline to 14-Week Endpoint in the Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient Global Impression - Improvement at Endpoint [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression of Improvement at Endpoint [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 14-Week Endpoint in 36-Item Short-Form Health Survey [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 14-Week Endpoint in Widespread Pain Index and Symptom Severity in American College of Rheumatology Fibromyalgia Diagnostic Criteria 2010 [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score within 24-hours in Patient Diary [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 14-Week Endpoint in BPI Pain Severity Items and Interference Items of the BPI-Modified Short Form Score [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 354 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Duloxetine 60 mg
Duloxetine hydrochloride 60 milligrams (mg) orally for 15 weeks
|
Drug: Duloxetine 60 mg
Duloxetine 60 milligram (mg) taken orally once every day for 15 weeks
Other Names:
|
|
Placebo Comparator: Placebo
Placebo orally for 15 weeks
|
Drug: Placebo
Placebo taken orally once every day for 15 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants fulfilling the following criteria in the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia
- Participants with pain rated severity 4 or over by BPI - average pain severity item (question 3)
Exclusion Criteria:
- Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators
- Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 IU/L or total bilirubin of not less than 1.6 mg/dL
- Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis
- Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment
- Participants with treatment-refractory fibromyalgia
- Participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by three-month or longer drug therapy
- Participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency
- Participants with an axis I condition according to DSM-IV, currently or within the past year, except for major depressive disorders
- Participants with a lifetime diagnosis of bipolar disorder or schizoaffective disorder; or any other disorder with psychotic symptoms - based on the clinical opinion of the investigator
- Participants with personality disorder or mental retardation
- Participants with uncontrolled angle closure glaucoma
- Participants with present or past history of uncontrolled seizures or convulsion disorders
- Participants with suicidal ideation within past 6 months, with suicidal attempt within past 1 year
- Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 6 months (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)
- Participants with past history of multiple episodes of drug allergy
- Female participants who are pregnant, lactating, or who want to get pregnant during the study period. Male participants who want his partner to get pregnant
- Females of child-bearing potential who can't agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study
- Participants with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol, but excluding nicotine and caffeine) within the past 1 year
- Participants who have a positive urine drug screen for any substance of abuse (phencyclidine, cocaine, antihypnotic agent, or cannabis).
- Participants previously treated with duloxetine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552057
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Locations
| Japan | |
| 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. | Recruiting |
| Miyagi, Japan, 982-0032 | |
| Contact: Eli Lilly | |
Sponsors and Collaborators
Eli Lilly and Company
Shionogi
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01552057 History of Changes |
| Other Study ID Numbers: | 14377, F1J-JE-HMGZ |
| Study First Received: | March 9, 2012 |
| Last Updated: | June 6, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013