A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flupirtine maleate capsule 100 mg (Mfg. By Ajanta Pharma) Vs. Flupirtine maleate capsule 100 mg in Acute Pain associated with Muscle Spasm and Inflammatory Conditions.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Changes in Restriction of Movement Score
研究概览
简要总结
This study is a a prospective, randomized, comparative, double blind and Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flupirtine maleate capsule 100 mg (Mfg. By Ajanta Pharma) Vs Flupirtine maleate capsule 100 mg (Reference Drug), for 7 days in 200 patients with acute pain associated with muscle spasm and inflammatory conditions. The study will start on 17 February 2010.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Primary efficacy endpoints are visual analog scale (VAS) score for pain and changes in restriction of movement score which will be measured on day 0, 3, 5 and 7. Secondary efficacy endpoint are changes in symptoms such as Stiffness, Swelling, Tenderness and Redness (will be measured on day 0, 3, 5 and 7) and improvement in patients and physicians global assessment of pain at day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Day(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of Tinea pedis and Tinea cruris confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test).
- •2.Written informed consent by patient.
- •3.Patient willing to follow up.
排除标准
- •1.Pregnant or nursing females.
- •2.Patient with impaired hepatic function defined as SGOT or SGPT 2.0 times the upper limit of the normal 3.Patient with impaired renal function, confirmed by serum creatinine 2.0 mg/dL 4.Patient who had participated in a medical, surgical or pharmaceutical investigation at the time of the study in which an investigational new drug was dispensed to the patient within last 6 months 5.Patient with history of hypersensitivity of Flupirtine and any topical analgesic preparations like balm, gel etc 6.Patients with Bile Outflow Disorders.
- •7.Patients with alcoholic abuse.
结局指标
主要结局
Changes in Restriction of Movement Score
时间窗: Day 0, Day 3, Day 5 and Day 7.
次要结局
- Improvement in Patients and Physicians Global Assessment of Pain(Day 7)
- Changes in Symptoms such as Stiffness, Swelling, Tenderness and Redness shall be evaluated at baseline and each visit(Day 0, Day 3, Day 5 and Day 7.)