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

NCT00327730 | Completed Phase 3

• 1 other identifier: E0646-AS91-301
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Muscle Spasm; Back Pain

Keywords

Muscle; Spasm; Back; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• The present study will be conducted with a secondary objective of comparing the tolerability of Eperisone-HCl (Myonal) versus placebo.

Interventions

Eperisone DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of either sex between 18 to 60 years of age.
• Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to:
• Spondylosis deformans
• Prolapsed Intervertebral Disc (PID)
• Muscle sprains with spasms
• Patients who are willing to take the medications as directed and willing to come for follow-ups.
• Patients who are willing to comply with the protocol requirements.
• Patients who are willing to give the written informed consent.

You may not qualify if:

• Patients with other associated spasm conditions like:
• Muscle sprains with spasms of hip/knee/ankle
• Traumatic pain with spasms
• Cervical Spondylitis
• Pain \& spasm associated with fractured bone.
• Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
• Patients with hypersensitivity to any of the ingredients of the test \& control formulations.
• Pregnant/Lactating women or women of child bearing potential not following adequate contraceptive measures.
• Patients unwilling or unable to comply with the study procedures.
• Patients having a history of severe acute infection, major surgery or trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding 8 weeks.
• Patients having severe renal insufficiency defined by a creatinine value above 2.5 mg/dl.
• Patients having severe hepatic insufficiency defined by an SGOT or SGPT value equal or higher than the threefold normal values of the respective laboratory reference value.
• Patients having any of the following disorders:
• Renal failure
• Bulimia

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Co., Ltd.: collaborator

Study Sites (4)

M.R. Medical College

Kalaburagi, Karnataka, 585 104, India

Location

Grant Medical College Sir J.J. Group of Hospitals

Byculla, Mumbai, Maharashtra, 400 008, India

Location

L.T. M. Medical College and General Hospital

Sion, Mumbai, Maharashtra, 400 022, India

Location

Post Graduate Institute of Medical Education and Research (PGI)

Chandigarh, Punjab, 160 012, India

Location

MeSH Terms

Conditions

Spasm; Back Pain; Pain

Interventions

eperisone

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Dilip Pawar

  Eisai Pharmaceuticals India Pvt. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 18, 2006
• Study Start: April 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

IN (4)