Effectiveness and safety of pregabalin versus milnacipran in patients with fibromyalgia – A randomized open label post marketing study
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in modified Fibromyalgia Impact Questionnare (FIQR)score from baseline.
研究概览
简要总结
Subjects diagnosed as having fibromyalgia by the neurologist will be enrolled after explaining the study details to the patients and obtaining written informed consent and will be randomized to open label milnacipran or pregabalin according to computer generated block randomization. Dose titration and attainment of a stable dose will be done in 1 month. Modified Fibromyalgia Impact Questionnare (FIQR), Brief pain inventory (BPI), Medical Outcomes study (MOS) sleep scale score, Sheehan Disability Scale (SDS) score will be recorded in case record forms at baseline, 2 months of treatment and 3 months of treatment. Safety of milnacipran and pregabalin will be assessed through out the study by monitoring Adverse Drug Reactions and causality will be assessed using WHO Adverse Drug reaction monitoring criteria.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed as having fibromyalgia according to 2010 ACR diagnostic criteria for fibromyalgia.
排除标准
- •1.Subjects not willing to take part in the study.
- •2.Major depressive or psychiatric disorder, suicidal tendency or ideation.
- •3.Pregnancy 4.Lactation 5.Uncontrolled hypertension 6.Hepatic dysfunction 7.History of glaucoma 8.Patients receiving MAO inhibitors (eg: selegeline) 9.Cardiac failure (NYHA class III-IV).
结局指标
主要结局
Change in modified Fibromyalgia Impact Questionnare (FIQR)score from baseline.
时间窗: 2 months, 3 months of treatment.
次要结局
- Change in Medical Outcomes Study (MOS) sleep scale score from baseline.(2 months, 3 months of treatment.)
- Change in Sheehan Disability scale (SDS) score from baseline.(2 months, 3 months of treatment.)
- Analysis of symptoms and laboratory abnormalities associated with fibromyalgia.(Baseline)
- Incremental cost effectiveness ratio (ICER) of treatment regimens(2 months, 3 months)
- Comparison of absolute Fibromyalgia Impact Questionnare (FIQR)score(Baseline, 2 months, 3 months of treatment.)
- Comparison of absolute brief pain inventory (BPI) score.(Baseline, 2 months, 3 months of treatment.)
- Comparison of absolute Medical Outcomes Study (MOS) sleep scale score.(Baseline, 2 months, 3 months of treatment.)
- Comparison of absolute Sheehan Disability scale (SDS) score.(Baseline, 2 months, 3 months of treatment.)
- Change in brief pain inventory (BPI) score from baseline.(2 months, 3 months of treatment.)
- Adverse events associated with milnacipran and pregabalin(Through out the study)
- Discontinuation of study medications and reason for discontinuation.(Through out the study)