CTRI/2009/091/000720
Completed
Phase 3
Clinical study to evaluate the efficacy and tolerability of FDC of S(+)-Etodolac and Paracetamol Tablet in acute musculoskeletal pain
Emcure Pharmaceuticals Ltd, Pune0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emcure Pharmaceuticals Ltd, Pune
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Male or female patients between 18\-65 years of age.
- •2\) Patients having acute musculoskeletal pain e.g. musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain
- •3\) Patients willing to give written informed consent and willing to comply with trial protocol.
Exclusion Criteria
- •1\) Patients previously sensitive to S\-Etodolac, to diclofenac, to paracetamol, to any other NSAID, or to any of the ingredients of the product
- •2\) Patients in whom substances with a similar action (e.g. Aspirin, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.
- •3\) Patients with active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer or chronic dyspepsia.
- •4\) Patients who have gastrointestinal bleeding or other active bleedings or bleeding disorders.
- •5\) Patients with Crohn?s disease or ulcerative colitis.
- •6\) Patients with a history/ presence of bronchial asthma.
- •7\) Patients with severe heart failure
- •8\) Patients with moderate to severe renal dysfunction
- •9\) Patients with severely impaired hepatic function
- •10\) Patients with hemorrhagic diathesis and other coagulation disorders
Outcomes
Primary Outcomes
Not specified
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