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 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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 ≥ 40 mm)
•4.Patients willing to give written informed consent and willing to comply with trial protocol

•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
•11.Patients with known myasthenia gravis
•12.Patients with known glaucoma
•13.Patients with any significant and uncontrolled hematological / metabolic /endocrinological (excluding type 2 diabetes mellitus) / neurological / psychiatric / respiratory / cardiovascular disorder
•14.Women who are pregnant, lactating, or of child bearing potential who are not practicing effective methods of contraception.
•15.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

发起方

Emcure Pharmaceuticals Ltd. Pune