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

An Open Label Extension Study of Phase 3 Trial of Duloxetine in Patients With Fibromyalgia

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

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