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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Collaborator: Eisai Co., Ltd.
• Treatments: Eperisone

Criteria

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.