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

Primary Purpose

Muscle Spasm; Back Pain

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Eperisone
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Spasm; Back Pain focused on measuring Muscle, Spasm, Back, Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M.R. Medical College
  • Grant Medical College Sir J.J. Group of Hospitals
  • L.T. M. Medical College and General Hospital
  • Post Graduate Institute of Medical Education and Research (PGI)

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
May 17, 2006
Last Updated
April 17, 2014
Sponsor
Eisai Inc.
Collaborators
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00327730
Brief Title
Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial
Official Title
Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
Collaborators
Eisai Co., Ltd.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasm; Back Pain
Keywords
Muscle, Spasm, Back, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Eperisone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The present study will be conducted with a secondary objective of comparing the tolerability of Eperisone-HCl (Myonal) versus placebo.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Hypo and Hyperthyroidism Nephrotic syndrome Anorexia nervosa Biliary obstruction Severe cardiac dysfunction. Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder. Patients that have received treatment with any investigational drug in the preceding 4 weeks. Patients likely to be non-compliant (alcohol, smoking or drug abusers). Any condition that, in the opinion of the investigator, does not justify patient's inclusion in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Dilip Pawar
Organizational Affiliation
Eisai Pharmaceuticals India Pvt. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
M.R. Medical College
City
Gulbarga
State/Province
Karnataka
ZIP/Postal Code
585 104
Country
India
Facility Name
Grant Medical College Sir J.J. Group of Hospitals
City
Byculla, Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 008
Country
India
Facility Name
L.T. M. Medical College and General Hospital
City
Sion, Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 022
Country
India
Facility Name
Post Graduate Institute of Medical Education and Research (PGI)
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160 012
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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