A clinical Trial in-patients Acute Pain associated with Muscle Spasm andInflammatory Conditions. Clinical trial is to study efficacy, safety and tolerability of Flupirtine maleate capsule 100 mg (Mfg. By Ajanta Pharma) in comparison to Flupirtine maleate capsule 100 mg (reference product).
- Conditions
- Health Condition 1: null- Acute Pain associated with Muscle Spasm and Inflammatory ConditionsHealth Condition 2: M629- Disorder of muscle, unspecified
- Registration Number
- CTRI/2009/091/001051
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. 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.
.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Restriction of Movement ScoreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Changes in Restriction of Movement ScoreTimepoint: Day 0, Day 3, Day 5 and Day 7.
- Secondary Outcome Measures
Name Time Method Changes in Symptoms such as Stiffness, Swelling, Tenderness and Redness shall be evaluated at baseline and each visitTimepoint: Day 0, Day 3, Day 5 and Day 7.;Improvement in Patients and Physicians Global Assessment of PainTimepoint: Day 7