An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination tablets containing Etodolac & Tolperisone hydrochloride in comparison with Tolperisone hydrochloride tablets in patients suffering from musculoskeletal disorders associated with painful muscle spasm.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- The degree of improvement in the composite score of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline.
Study Overview
Brief Summary
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination tablets of Etodolac 400 mg & Tolperisone hydrochloride 150 mg and Tolperisone hydrochloride 150 mg tablets given thrice a day each for a maximum of 14 days or till complete muscle spasm relief is obtained, whichever is earlier; in 200 patients with musculoskeletal disorders associated with painful muscle spasm that will be conducted in five centers only in India. The primary outcome measures will be the degree of improvement in the composite score of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline..
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients of either sex between the age of 18-60 years.
- •2.Patients with an established diagnosis of musculoskeletal disorders associated with painful muscle spasm of at least moderate severity at the time of enrolment into the study.
- •3.Informed consent of the patient/relative/legal representative.
Exclusion Criteria
- •1.Pregnancy & Lactation.2.Patients with hepatic and / or renal insufficiency.3.Patients with myasthenia gravis.4.Patients with active peptic ulceration within the last 6 months.5.Patients suffering from coronary heart disease, uncontrolled hypertension, congestive heart failure or any other significant cardiovascular disorder.6.Patients suffering from any hemorrhagic diasthesis.
- •7.Patients with bronchial asthma, rhinitis, urticaria, or other allergic reactions induced by aspirin or other NSAIDs.8.Patients with hypersensitivity to Etodolac, Tolperisone hydrochloride or any other components of the formulations.9.Patients with any other serious concurrent illness or malignancy.10.Patients with continuing history of alcohol and / or drug abuse.11.Participation in another clinical trial in the past 3 months.
Outcomes
Primary Outcomes
The degree of improvement in the composite score of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline.
Time Frame: 0,3,7,10 & 14 days
Secondary Outcomes
- (1)The degree of improvement in the individual scores of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline.((2)The investigators? global assessment of efficacy at the end of the study.)