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).

Phase 3

Completed

• Conditions: Disorder of muscle, unspecified,

• Registration Number: CTRI/2009/091/001051
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-17
• Last Update Posted: 2018-11-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 Score	Day 0, Day 3, Day 5 and Day 7.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Deeksha Hospital; 🇮🇳 Bangalore, KARNATAKA, India

New Hope Medical Centre; 🇮🇳 Chennai, TAMIL NADU, India

Pondy Ortho Clinic; 🇮🇳 Pondicherry, PONDICHERRY, India

Upadhyaya Nursing Home; 🇮🇳 Mumbai, MAHARASHTRA, India

Deeksha Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr. S.Somshekar

Principal investigator

9845351508

drshekarortho@gmail.com