CTRI/2009/091/000114
Completed
Phase 3
Clinical study to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain
Emcure Pharmaceuticals Limited Pune0 sites110 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emcure Pharmaceuticals Limited Pune
- Enrollment
- 110
- 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.
- •comply with trial protocol.
Exclusion Criteria
- •1\.Patients previously sensitive to dexketoprofen, 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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