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Clinical Trials/CTRI/2009/091/001067
CTRI/2009/091/001067CompletedPhase 3

AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTRE 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

Intas Pharmaceuticals Limited0 sites204 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
204
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility 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

  • •(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.

Investigators

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