Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain|
- The present study will be conducted with an objective of comparing the efficacy of Eperisone-HCl (Myonal) versus placebo in the treatment of acute musculoskeletal spasm associated with low back pain.
- The present study will be conducted with a secondary objective of comparing the tolerability of Eperisone-HCl (Myonal) versus placebo.
|Study Start Date:||October 2006|
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.
|M.R. Medical College|
|Gulbarga, Karnataka, India, 585 104|
|Grant Medical College Sir J.J. Group of Hospitals|
|Byculla, Mumbai, Maharashtra, India, 400 008|
|L.T. M. Medical College and General Hospital|
|Sion, Mumbai, Maharashtra, India, 400 022|
|Post Graduate Institute of Medical Education and Research (PGI)|
|Chandigarh, Punjab, India, 160 012|
|Study Director:||Dr. Dilip Pawar||Eisai Pharmaceuticals India Pvt. Ltd|