Health Condition 1: null- Musculoskeletal disorders associated with painful muscle spasm Health Condition 2: M628- Other specified disorders of muscle Health Condition 3: M628- Other specified disorders of muscle
Conditions
Interventions
Intervention1: Fixed-dose combination tablets of Etodolac 400 mg &
Tolperisone hydrochloride 150 mg: Thrice in a day for a maximum of 14 days or till complete muscle spasm relief is obtained, whichever is earlier
Control Intervention1: Tolperisone hydrochloride 150 m
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 0,3,7,10 & 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| (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.Timepoint: 0,3,7,10 & 14 days | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Outcome results
None listed