A clinical trial to study the effects of two drugs, Tolperisone and Diclofenac in patients suffering from acute muscle spasms

Phase 3

Completed

• Conditions: Acute Muscle Spasms

• Registration Number: CTRI/2010/091/006069
• Lead Sponsor: Themis Medicare Limited

Brief Summary

This study is a controlled, randomized, open, comparative, parallel, 2-arm study to evaluate the efficacy and safety of FDC tablet containing Tolperisone 150 mg and Diclofenac 50 mg in patients suffering from acute muscle spasms.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients of either sex in the age group between 18 to 70 years.
• Patients painful muscle spasms and contractions associated with cervical and lumbar spondylosis, rheumatoid arthritis, osteoarthritis, blunt superficial trauma, low back pain.
• Subjects who provide a written informed consent to abide by the study requirements.

Exclusion Criteria

Patients with acute muscle spasms who need parenteral therapy / surgery / hospital admission for management.2. Patients treated with any other oral / parenteral muscle relaxants, analgesics (NSAIDS & Opioids) medications within 1 week prior to the study.3. Patients suffering from organic neurological disorders (Upper motor neuron disorders, cerebral palsy, pyramid tract injury, multiple sclerosis, cerebrovascular events, myelopathy, encephalomyelitis, etc.), peripheral vascular diseases (arteriosclerosis obliterans, diabetic angiopathy, thrombangiitis obliterans, Raynaud's disease, diffuse scleroderma) as well as syndromes developing on the basis of impaired vascular innervation (acrocyanosis, dysbasia angioneurotica intermittent), Little's diseases and other encephalopathies accompanied by dystonia.4. Patients suffering from myasthenia gravis or myopathies with muscle weakness as the prominent symptom.5. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.6. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.7. Pregnant and lactating females.8. Simultaneous participation in another clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity (recorded on VAS), tenderness (graded from 0 to 3), joint mobility (recorded on VAS), Spasm relief (recorded on VAS), need for rescue medication. Time needed for the patient to be symptom free.	0, 4 days, 7 days, 14 days, 21 days

Secondary Outcome Measures

Name	Time	Method
Digit / alphabet cancellation test, reaction time : auditory and visual using the reaction time apparatus, flicker fusion frequency using the flicker fusion apparatus, measurement of hand grip strength, ADR recording, blood investigations	0, 21 days

Trial Locations

Locations (3)

Adarsh Health Clinic,; 🇮🇳 Mumbai, MAHARASHTRA, India

Government Medical College; 🇮🇳 Aurangabad, MAHARASHTRA, India

Post Graduate Institute of Medical Education & Research (PGIMER),; 🇮🇳 Chandigarh, CHANDIGARH, India

Adarsh Health Clinic,

🇮🇳Mumbai, MAHARASHTRA, India

Dr. Sunil Shetty

Principal investigator

9821288076