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Clinical Trials/CTRI/2009/091/000388
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Emcure Pharmaceuticals Ltd. Pune

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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