Health Condition 1: null- Acute painful soft tissue injury
Conditions
Interventions
Intervention1: IN-PHARM-002: 80 mg three times a day for 7 days
Control Intervention1: IBUPROFEN: 400 mg three times a day for 7 days
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Change in the visual analog scale at endpoint compared to baseline.Timepoint: At the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 At every visit | — |
Countries
India
Contacts
Public ContactDr HV Barkate
Intas pharmaceuticals
Outcome results
None listed