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

April 17, 2014 updated by: Eisai Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Gulbarga, Karnataka, India, 585 104
        • M.R. Medical College
    • Maharashtra
      • Byculla, Mumbai, Maharashtra, India, 400 008
        • Grant Medical College Sir J.J. Group of Hospitals
      • Sion, Mumbai, Maharashtra, India, 400 022
        • L.T. M. Medical College and General Hospital
    • Punjab
      • Chandigarh, Punjab, India, 160 012
        • Post Graduate Institute of Medical Education and Research (PGI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients of either sex between 18 to 60 years of age.

  2. Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to:

    • Spondylosis deformans
    • Prolapsed Intervertebral Disc (PID)
    • Muscle sprains with spasms
  3. Patients who are willing to take the medications as directed and willing to come for follow-ups.
  4. Patients who are willing to comply with the protocol requirements.
  5. Patients who are willing to give the written informed consent.

Exclusion Criteria:

  1. 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.
  2. Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
  3. Patients with hypersensitivity to any of the ingredients of the test & control formulations.
  4. Pregnant/Lactating women or women of child bearing potential not following adequate contraceptive measures.
  5. Patients unwilling or unable to comply with the study procedures.
  6. Patients having a history of severe acute infection, major surgery or trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding 8 weeks.
  7. Patients having severe renal insufficiency defined by a creatinine value above 2.5 mg/dl.
  8. 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.

  9. Patients having any of the following disorders:

    • Renal failure
    • Bulimia
    • Hypo and Hyperthyroidism
    • Nephrotic syndrome
    • Anorexia nervosa
    • Biliary obstruction
    • Severe cardiac dysfunction.
  10. Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder.
  11. Patients that have received treatment with any investigational drug in the preceding 4 weeks.
  12. Patients likely to be non-compliant (alcohol, smoking or drug abusers).
  13. Any condition that, in the opinion of the investigator, does not justify patient's inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Collaborators

Eisai Co., Ltd.

Investigators

  • Study Director: Dr. Dilip Pawar, Eisai Pharmaceuticals India Pvt. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (Estimate)

May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E0646-AS91-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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