An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Duloxetine
Intervention description: Administered Orally
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

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