A clinical trial to study the effects of two drugs, fixed dose combination tablets of Etodolac & Tolperisone hydrochloride and Tolperisone hydrochloride tablets in patients with musculoskeletal disorders associated with painful muscle spasm.
- Conditions
- Health Condition 1: null- Musculoskeletal disorders associated with painful muscle spasmHealth Condition 2: M628- Other specified disorders of muscleHealth Condition 3: M628- Other specified disorders of muscle
- Registration Number
- CTRI/2009/091/001021
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method