NCT01621191已完成3 期
An Open Label Extension Study of Phase 3 Trial of Duloxetine in Patients With Fibromyalgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced an Adverse Event (AE)
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of duloxetine in participants with fibromyalgia at long-term use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
60 mg Duloxetine
Experimental
Duloxetine 20 milligrams (mg) taken orally once every day for 1 week, followed by 40 mg taken orally once every day for 1 week, and then 60 mg taken orally once every day for 48 weeks
干预措施: Duloxetine (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event (AE)
时间窗: Baseline through 53 weeks
A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
次要结局
- 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(Baseline, 50 weeks)
- 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(Baseline, 50 weeks)
- Patient Global Impression-Improvement (PGI-I) at Endpoint(50 weeks)
- Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores(Baseline, 50 weeks)
- Clinical Global Impression-Improvement (CGI-I) at Endpoint(50 weeks)
- Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)(Baseline, 50 weeks)
- Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)(Baseline, 50 weeks)
研究者
研究点 (1)
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