CTRI/2010/091/001343
Completed
Phase 3
Clinical trial to assess the efficacy and safety of Fixed Dose Combination of Dexketoprofen Trometamol and Dicyclomine Hydrochloride Injection in the treatment of Acute Colicky Pain
Emcure Pharmaceuticals Ltd. Pune0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emcure Pharmaceuticals Ltd. Pune
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female patients between 18 to 65 years of age
- •2\.Patients presenting with acute colicky pain in the flank and/or radiating to the abdomen or genitalia.
- •3\.Moderate to severe pain on Visual Analogue Scale (VAS \&\#8805; 40 mm)
- •4\.Patients willing to give written informed consent and willing to comply with trial protocol
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\.Patients on any anti\-inflammatory or other therapy known to affect the study outcome.
- •3\.Patients with active or suspected gastrointestinal ulcer/ history of gastrointestinal ulcer/ chronic dyspepsia or gastrointestinal bleeding.
- •4\.Patients with known Crohn?s disease or ulcerative colitis
- •5\.Patients with history of bronchial asthma
- •6\.Patients with known severe heart failure/ moderate to severe renal dysfunction (Creatinine clearance \< 50 ml/min.) or severely impaired hepatic function (Child\- Pugh score 10\- 15\)
- •7\.Patients with hemorrhagic diathesis and other coagulation disorders
- •8\.Any contraindication to use of NSAID
- •9\.Drug addiction or alcoholism
- •10\.Patients with diagnosed gastrointestinal obstruction
Outcomes
Primary Outcomes
Not specified
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