Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Efficacy and safety of Fixed Dose Combination of Dexketoprofen Trometamol and Dicyclomine Hydrochloride Injection
Scientific Title of Study
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
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
EPL/2010/DD/01
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr. Onkar Swami, MD
Designation
Affiliation
Address
Emcure Pharmaceuticals Ltd. Rajiv Gandhi IT Park Phase I, MIDC Pune MAHARASHTRA 411057 India
Phone
020-39821000
Fax
020-39821019
Email
Onkar.Swami@emcure.co.in
Details of Contact Person Scientific Query
Name
Dr. Onkar Swami, MD
Designation
Affiliation
Address
Emcure Pharmaceuticals Ltd. Rajiv Gandhi IT Park Phase I, MIDC Pune MAHARASHTRA 411057 India
Phone
020-39821000
Fax
020-39821019
Email
Onkar.Swami@emcure.co.in
Details of Contact Person Public Query
Name
Dr. Onkar Swami, MD
Designation
Affiliation
Address
Emcure Pharmaceuticals Ltd. Rajiv Gandhi IT Park Phase I, MIDC Pune MAHARASHTRA 411057 India
Phone
020-39821000
Fax
020-39821019
Email
Onkar.Swami@emcure.co.in
Source of Monetary or Material Support
Emcure Pharmaceuticals Ltd. Pune
Primary Sponsor
Name
Emcure Pharmaceuticals Ltd. Pune
Address
Type of Sponsor
Details of Secondary Sponsor
Name
Address
NONE
Countries of Recruitment
India
Sites of Study
No of Sites = 20
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr. Sudhir Kumar Bhatnagar, MD
Abhinav Multispeciality Hospital
Kamal Chowk,Naya Nakasha-440017 Nagpur MAHARASHTRA
Dr. S. Balamurugan, MBBS, DTCD, DNB
Chest Research Centre
2 Janki Nagar Extension,Valasaravakkam-600087 Chennai TAMIL NADU
Dr. P. T. Jamdade, MS
Department of Surgery
Dr. Shankarrao Chavan Govt. Medical College and Hospital,Vazirabad-431601 Nanded MAHARASHTRA
09860951000
prashantshirure@yahoo.com
Dr. Vijay V. Kamat, MS, DNB
Department of Surgery KIMS
Karnatak Institute of Medical Science,Bengeri Road, Keshwapur-580023
09448110403
kamatvv@gmail.com
Dr. Ashish Badadare, MD (Med)
Giridhar Clinic
Oshiya corner building,,Sukhsagar Nagar,-411046 Pune MAHARASHTRA
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
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
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 injection
4.Patient?s clinical global impression for change in pain
5.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
Target Sample Size
Total Sample Size="200" Sample Size from India="" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
Date Missing
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
22/09/2010
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="" Months="0" Days="0"
Recruitment Status of Trial (Global)
Completed
Recruitment Status of Trial (India)
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.