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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ClinicalTrials.gov Identifier: NCT00327730 |
Recruitment Status :
Completed
First Posted : May 18, 2006
Last Update Posted : April 21, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Muscle Spasm; Back Pain | Drug: Eperisone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients of either sex between 18 to 60 years of age.
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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:
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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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327730
India | |
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 |
Responsible Party: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT00327730 |
Other Study ID Numbers: |
E0646-AS91-301 |
First Posted: | May 18, 2006 Key Record Dates |
Last Update Posted: | April 21, 2014 |
Last Verified: | April 2014 |
Muscle Spasm Back Pain |
Muscle Cramp Spasm Back Pain Low Back Pain Pain Neurologic Manifestations Neuromuscular Manifestations Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Eperisone Anticonvulsants |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Parasympatholytics Autonomic Agents Vasodilator Agents |