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

Phase 3

Completed

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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 ≥ 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
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients having ≥ 50 % pain relief within 8 hoursTimepoint: 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 <br>2.Comparison of sum analogue of pain intensity difference (SAPID) <br>3.Comparison of pain intensity difference (PID) at 8th hour of injection<br>4.Patient?s clinical global impression for change in pain<br>5.Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator <br>6.Subject?s global assessment about the tolerability of the drug <br>7.Physician?s global assessment about the tolerability of the drugTimepoint: Baseline and at the intervals of 1, 2, 4, 6 and 8 hours after the injection