NCT00327730

Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial

Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of Eperisone HCl in the treatment of Acute Musculoskeletal spasm associated with Low-Back Pain.

Detailed description

This is a multi-center trial, which will be conducted in a total of 240 patients (120 patients in each treatment group). Patients attending the out-patient setting of traumatology and orthopedic departments of the study centers will be screened for lumbar pain and spasm by clinical and radiological examination for inclusion. In this study, it has been planned to enroll a total of 240 patients with 120 patients in each group. The total duration of treatment will be 14 days. Patients will be screened for baseline parameters and will then be randomized, as per the predetermined randomization schedule, into two groups. Patients will be treated with either Eperisone-HCl (Myonal) or placebo for a period of 14 days. After the baseline-screening visit (Day 1), the patients would be asked to follow up on day 3, day 7, and day 14. During each visit, a complete general examination and clinical evaluation of efficacy parameters would be done. Adverse events would be monitored during the study period and would be recorded in the Case Report Form (CRF). At the end of the treatment, Global Assessment of Response to Therapy by Physicians and Patients (PGART) would be done for efficacy and tolerability separately.

Conditions

• Muscle Spasm; Back Pain

Interventions

Type	Name	Description
DRUG	Eperisone

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2006-05-18
• Last updated: 2014-04-21

Locations

4 sites across 1 country: India