CTRI Number |
CTRI/2009/091/000114 [Registered on: 31/03/2009] |
Last Modified On: |
26/10/2012 |
Post Graduate Thesis |
|
Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Clinical study of the combination of Dexketoprofen and Paracetamol in acute musculoskeletal pain |
Scientific Title of Study
Modification(s)
|
Clinical study to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain |
Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Identifier |
EPL/DXKT-P/2008/01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr N J Karne |
Designation |
|
Affiliation |
|
Address |
Pune Institute of Accident and Orthopedics, Krishna Chambers, Near Swargate, Pune - Satara Road Pune MAHARASHTRA 411037 India |
Phone |
020-24265148 |
Fax |
|
Email |
backache@vsnl.com |
|
Details of Contact Person Scientific Query
Modification(s)
|
Name |
Dr Sudhir Surwade |
Designation |
|
Affiliation |
Manager-Clinical Projects |
Address |
Emcure Pharmaceuticals Ltd., Phase I, MIDC, Hinjwadi
Pune MAHARASHTRA 411057 India |
Phone |
020-39821000 |
Fax |
020-39821019 |
Email |
Sudhir.Surwade@emcure.co.in |
|
Details of Contact Person Public Query
Modification(s)
|
Name |
Dr Sudhir Surwade |
Designation |
|
Affiliation |
|
Address |
Emcure Pharmaceuticals Ltd., Phase I, MIDC, Hinjwadi
Pune MAHARASHTRA 411057 India |
Phone |
020-39821000 |
Fax |
020-39821019 |
Email |
Sudhir.Surwade@emcure.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
Emcure Pharmaceuticals Limited |
|
Primary Sponsor
Modification(s)
|
Name |
Emcure Pharmaceuticals Limited Pune |
Address |
Survey No. 255/2, Phase I, Hinjwadi MIDC, Pune-411 057, |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
No of Sites = 7 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr. Paresh Patil |
City Medical Center |
City Medical Center,Shaniwar Peth-415110
|
02164225959
alaukika@dataone.in |
Dr. M. S. Hardikar |
Hardikar Hospital, Pune |
Hardikar Hospital,Shivaji Nagar-411005 Pune MAHARASHTRA |
02025535326
hardikar@vsnl.com |
Dr J B Panse |
Panse Clinic, Pune |
Panse Clinic,10/73, Agarkar Nagar-411001 Pune MAHARASHTRA |
02026126524
jbpanse@bsnl.in |
Dr. Sandeep Patil |
Patil Orthopaedic Hospital |
Patil Orthopaedic Hospital,Shaniwar Peth-415110
|
02164225776
none |
Dr. N. J. Karne |
Pune Institute of Accident and Orthopedics, Pune |
Pune Institute of Accident and Orthopedics,Krishna Chambers, Satara Road-411037 Pune MAHARASHTRA |
02024265148
backache@vsnl.com |
Dr. N. S. Dhaniwala |
Shri Shankarrao Chavan Government Medical College, Vajirabad, Nanded |
Professor and Head, Department of Orthopedics,,Shri Shankarrao Chavan Government Medical College, Vajirabad, Nanded-431601 Nanded MAHARASHTRA |
9422188450
|
Dr. Mahesh Patil |
Suman Accident Hospital, Pune |
Suman Accident Hospital,Neeta Park, Yerwada-411006 Pune MAHARASHTRA |
02065008699
drmaheshpatil@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 8 |
Name of Committee |
Approval Status |
IEC-Shri Shankarrao Chavan GMC, Nanded- For Dr. N.S. Dhaniwala |
Approved |
Kotbagi Hospital- Independant Ethics Committee for Dr. D. D. Kekare |
Approved |
Kotbagi Hospital- Independant Ethics Committee for Dr. J. B. Panse |
Approved |
Kotbagi Hospital- Independant Ethics Committee for Dr. M. S. Hardikar |
Approved |
Kotbagi Hospital- Independant Ethics Committee for Dr. Mahesh Patil |
Approved |
Kotbagi Hospital- Independant Ethics Committee for Dr. N. J. Karne |
Approved |
Kotbagi Hospital- Independant Ethics Committee for Dr. Paresh Patil |
Approved |
Kotbagi Hospital- Independant Ethics Committee for Dr. Sandeep Patil |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Acute musculoskeletal pain, |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
FDC of Dexketoprofen trometamol (25 mg) and Paracetamol (500 mg) |
Dose and duration- One tablet to be taken orally, thrice daily for three consecutive days. |
Comparator Agent |
FDC of Diclofenac sodium (50 mg) and Paracetamol (500 mg) |
Dose and duration- One tablet to be taken orally, thrice daily for three consecutive days. |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Male or female patients between 18-65 years of age.
2. Patients having acute musculoskeletal pain e.g. musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain
3. Patients willing to give written informed consent and willing to comply with trial protocol.
comply with trial protocol.
|
|
ExclusionCriteria |
Details |
1. Patients previously sensitive to dexketoprofen, to diclofenac, to paracetamol, to any other NSAID, or to any of the ingredients of the product
2. Patients in whom substances with a similar action (e.g. Aspirin, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.
3. Patients with active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer or chronic dyspepsia.
4. Patients who have gastrointestinal bleeding or other active bleedings or bleeding disorders.
5. Patients with Crohn?s disease or ulcerative colitis.
6. Patients with a history/ presence of bronchial asthma.
7. Patients with severe heart failure
8. Patients with moderate to severe renal dysfunction
9. Patients with severely impaired hepatic function
10. Patients with hemorrhagic diathesis and other coagulation disorders
11. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception
12. Treatment with other analgesic and/or anti-inflammatory agent
13. Patients who will receive some other drug during the study besides that in the protocol that could alter the bioavailability of the study drug
14. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Investigator Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
The responder rate, defined as the percent of patients showing at least 50% improvement on VAS. |
0,1,6,12,24,48 and 72 hours |
|
Secondary Outcome
Modification(s)
|
Outcome |
TimePoints |
Total pain relief score (TOTPAR) on VS. |
0,1,6,12,24,48 and 72 hours |
Patient?s global assessment of the efficacy of the drug |
0,1,6,12,24,48 and 72 hours |
Physician?s global assessment of the efficacy of the drug |
0,1,6,12,24,48 and 72 hours |
Sum of pain intensity differences (SPID) on categorical verbal scale (VS). |
0,1,6,12,24,48 and 72 hours |
Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS) |
0,1,6,12,24,48 and 72 hours |
|
Target Sample Size
Modification(s)
|
Total Sample Size="110" Sample Size from India="110"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
16/03/2009 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
16/03/2009 |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0" Months="0" Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a comparative, randomized, multicentric, clinical trial to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain. This study is presently being conducted in 100 patients from various centers in India. Patients will be randomized to receive either Fixed Dose Combination of Dexketoprofen trometamol (25 mg) and Paracetamol (500 mg) or Fixed Dose Combination of Diclofenac sodium (50 mg) and Paracetamol (500 mg). Dose will be one tablet to be taken orally, thrice daily for three consecutive days. Major outcomes measured will be Responder rate, reduction in pain intensity on VAS, Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS), Sum of pain intensity differences (SPID) on categorical verbal scale (VS), Total pain relief score (TOTPAR) on VS, patients and physician’s global assessment and ADR. |