Phase III clinical trial for Evaluation of Efficacy and Safety of IN-PHARM-002 in Comparison with Ibuprofen in adult patients with acute painful soft tissue injury.
- Conditions
- Health Condition 1: null- Acute painful soft tissue injury
- Registration Number
- CTRI/2009/091/001067
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 204
(1)Patients of either sex between 18 and 60 years of age diagnosed with acute painful soft tissue injury.
(2)Subjects willing to provide written informed consent
In case of female with child bearing potential Surgically sterile or using a medically accepted means of contraception with negative serum pregnancy test
(1)Concomitant peptic ulcer, gastrointestinal bleeding and asthma.
(2)Serious heart, blood, renal or hepatic diseases.
(3)Clinically significant abnormalities on physical examination or laboratory tests.
(4)Ongoing use of prohibited medications [i.e. other NSAIDs, opioid analgesics and systemic corticosteroids].
(5)Pregnancy or lactation.
(6)As deemed inappropriate for enrollment by investigating physician due to other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Change in the visual analog scale at endpoint compared to baseline.Timepoint: At the end of treatment
- Secondary Outcome Measures
Name Time Method (1)Change in investigators global assessment of pain relief at the endpoint compared to baseline. (2)Percent of patients requiring rescue medication.Timepoint: At the end of treatment <br/ ><br>At every visit