Efficacy and safety of Fixed Dose Combination of Dexketoprofen Trometamol and Dicyclomine Hydrochloride Injection

Phase 3

• Conditions: Acute Renal Colic

• Registration Number: CTRI/2010/091/001343
• Lead Sponsor: Emcure Pharmaceuticals Ltd. Pune

Brief Summary

This multicentric, randomized, open label, comparative clinical trial is planned to compare the efficacy and safety of FDC of dexketoprofen trometamol 50 mg and dicyclomine hydrochloride 20 mg IM injection with FDC of diclofenac and dicyclomine hydrochloride IM injection in patients with acute renal colic. Subjects satisfying inclusion and exclusion criteria will be randomized in 1:1 to receive FDC of dexketoprofen trometamol 50 mg and dicyclomine hydrochloride 20 mg IM injection or FDC of diclofenac and dicyclomine hydrochloride IM injection. Subjects will be evaluated for pain intensity on visual analogue scale (VAS) just before drug administration of study medicine (Baseline VAS) and then at the intervals of 1, 2, 4, 6 and 8 hours after the injection. Primary and secondary efficacy variables and safety variables will be noted and analyzed.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Male and female patients between 18 to 65 years of age2.Patients presenting with acute colicky pain in the flank and/or radiating to the abdomen or genitalia.

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 colitis5.Patients with history of bronchial asthma6.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 disorders8.Any contraindication to use of NSAID9.Drug addiction or alcoholism10.Patients with diagnosed gastrointestinal obstruction11.Patients with known myasthenia gravis12.Patients with known glaucoma13.Patients with any significant and uncontrolled hematological / metabolic /endocrinological (excluding type 2 diabetes mellitus) / neurological / psychiatric / respiratory / cardiovascular disorder14.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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients having ≥ 50 % pain relief within 8 hours	At the intervals of 1, 2, 4, 6 and 8 hours after the injection

Secondary Outcome Measures

Name	Time	Method
1.Time of onset of significant decrease in VAS scores 2.Comparison of sum analogue of pain intensity difference (SAPID) 3.Comparison of pain intensity difference (PID) at 8th hour of injection4.Patient?s clinical global impression for change in pain5.Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator 6.Subject?s global assessment about the tolerability of the drug 7.Physician?s global assessment about the tolerability of the drug	Baseline and at the intervals of 1, 2, 4, 6 and 8 hours after the injection

Trial Locations

Locations (20)

Abhinav Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Chest Research Centre; 🇮🇳 Chennai, TAMIL NADU, India

Department of Surgery; 🇮🇳 Nanded, MAHARASHTRA, India

Department of Surgery KIMS; 🇮🇳 Road,, India

Giridhar Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Ketki Hospital; 🇮🇳 Aurangabad, BIHAR, India

Modern Stone Care & Urology Research Centre; 🇮🇳 Shaniwar, India

Pawana Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Prabha Vithal Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Prabhavati Multispeciality Hospital and Reserch Centre; 🇮🇳 Latur, MAHARASHTRA, India

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Abhinav Multispeciality Hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr. Sudhir Kumar Bhatnagar, MD

Principal investigator