Clinical trial NCT01621191: An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)
Official title: An Open Label Extension Study of Phase 3 Trial of Duloxetine in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Shionogi
First posted: 2012-06-18
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety and efficacy of duloxetine in participants with fibromyalgia at long-term use.


Eligibility criteria: Inclusion Criteria:

* Participants who have completed the 15-week treatment in the preceding study HMGZ
* Participants who wish continuous treatment with duloxetine after the preceding study
* Participants are able to give their own written consent

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 International Units/Liter (IU/L) or total bilirubin of not less than 1.6 milligrams/deciliter (mg/dL) at Week 0 (Visit 8 of the preceding study)
* Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis at Week 0 (Visit 8 of the preceding study)
* Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment
* 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 uncontrolled angle closure glaucoma
* Participants who received monoamine oxidase (MAO) inhibitors within 14 days before Week 0 (Visit 8 of the preceding study) or need to receive a MAO inhibitor within 5 days after study discontinuation
* Participants who have experienced suicidal ideation or suicide attempt during the preceding study
* Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring in the preceding study (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)
* 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 cannot 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 assessed ineligible by the investigator (sub-investigator) for other reasons

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Baseline through 53 weeks
Secondary outcomes:
measure: Patient Global Impression-Improvement (PGI-I) at Endpoint
timeFrame: 50 weeks
measure: Clinical Global Impression-Improvement (CGI-I) at Endpoint
timeFrame: 50 weeks
measure: Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Baseline, 50 weeks
measure: 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
timeFrame: Baseline, 50 weeks
measure: Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
timeFrame: Baseline, 50 weeks
measure: Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline, 50 weeks
measure: 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
timeFrame: Baseline, 50 weeks
Other outcomes:
Locations:
city: Miyagi
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: