Status:
COMPLETED
Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Muscle Spasm; Back Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 depar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00327730
Start Date
April 1 2006
End Date
June 1 2006
Last Update
April 21 2014
Active Locations (4)
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1
M.R. Medical College
Kalaburagi, Karnataka, India, 585 104
2
Grant Medical College Sir J.J. Group of Hospitals
Byculla, Mumbai, Maharashtra, India, 400 008
3
L.T. M. Medical College and General Hospital
Sion, Mumbai, Maharashtra, India, 400 022
4
Post Graduate Institute of Medical Education and Research (PGI)
Chandigarh, Punjab, India, 160 012