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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Shionogi
• Treatments: Duloxetine Hydrochloride

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