CTRI/2009/091/000388
Completed
Phase 3
A clinical trial to assess the efficacy and safety of Injection Dexketoprofen Trometamol in the treatment of Post-operative Pain
Emcure Pharmaceuticals Ltd. Pune0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emcure Pharmaceuticals Ltd. Pune
- 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 undergoing surgery for (Inguinal/Incisional/Umbilical/Congenital/Other) hernia repair
- •3\. Willing to give written informed consent and willing to comply with the trial protocol.
- •4\. Patients with normal baseline laboratory parameters.
Exclusion Criteria
- •1\. Patients with known hypersensitivity to the study medications and /or history of any drug allergy or intolerance to NSAIDs or any anesthetic medication.
- •2\. Complication during or after surgical procedure.
- •3\. Patients on any anti\-inflammatory or other therapy known to affect the study outcome.
- •4\. Patients with active or suspected gastrointestinal ulcer / history of gastrointestinal ulcer / chronic dyspepsia or gastrointestinal bleeding.
- •5\. Patients with Crohn?s disease or ulcerative colitis
- •6\. Patients with history of bronchial asthma
- •7\. Patients with severe heart failure / moderate to severe renal dysfunction (Creatinine clearance \< 50 ml/min) or severely impaired hepatic function (Child\- Pugh score 10\- 15\)
- •8\. Patients with hemorrhagic diathesis and other coagulation disorders
- •9\. Any contraindication to use of NSAID.
- •10\. Drug addiction or alcoholism.
Outcomes
Primary Outcomes
Not specified
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