Phase 3
Completed N=149
An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)
Source: ClinicalTrials.gov NCT01621191 ↗Enrolled (actual)
149
Serious AEs
5.4%
Results posted
Feb 2015
Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event (AE) — 138 participants
Summary
The purpose of the study is to assess the safety and efficacy of duloxetine in participants with fibromyalgia at long-term use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
138 | — |
| SECONDARY Patient Global Impression-Improvement (PGI-I) at Endpoint |
2.48 | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) at Endpoint |
2.34 | — |
| SECONDARY Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ) |
-6.00 | — |
| SECONDARY 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 |
-1.31; -1.53; -1.26; -1.47; -0.72; -0.82 | — |
| SECONDARY Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores |
4.26; 4.02; 6.89; 4.14; 0.16; 3.26 | — |
| SECONDARY Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II) |
-0.94 | — |
| SECONDARY 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 |
-1.46; -0.37 | — |
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
Data sourced from ClinicalTrials.gov (NCT01621191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.