| CTRI Number |
CTRI/2009/091/001067 [Registered on: 17/02/2010] |
| Last Modified On: |
26/09/2014 |
| 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)
|
Phase III clinical trial for Evaluation of Efficacy and Safety of IN-PHARM-002 in Comparison with Ibuprofen in adult patients with acute painful soft tissue injury. |
Scientific Title of Study
Modification(s)
|
AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTRE CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF IN-PHARM-002 IN COMPARISON WITH IBUPROFEN IN ADULT PATIENTS WITH ACUTE PAINFUL SOFT TISSUE INJURY |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| CT/IN-PHARM-002/APASTI/III/09 |
DCGI |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rajendra C Rane |
| Address |
Intas Pharmaceuticals
Chinubhai Centre
Ashram Road,
Ahmedabad
As above
Ahmadabad
GUJARAT
380009
India |
| Phone |
26576655 |
| Fax |
26576616 |
| Email |
rane@intaspharma.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr H V Barkate |
| Address |
Medical Services Intas Pharmaceuticals Ltd
Chinubhai Centre
Ashram road
As above
Ahmadabad
GUJARAT
380009
India |
| Phone |
66117401 |
| Fax |
26576616 |
| Email |
drbarkate@intaspharma.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr HV Barkate |
| Address |
Medical Services, Intas Pharmaceuticals Ltd.
Chinubhai centre
Ahmedabad
As above
Ahmadabad
GUJARAT
380009
India |
| Phone |
66117401 |
| Fax |
26576616 |
| Email |
drbarkate@intaspharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Intas Pharmaceuticals Limited, Ahmedabad |
|
Primary Sponsor
Modification(s)
|
| Name |
Intas Pharmaceuticals Limited |
| Address |
2nd Floor Chinubhai Center Ashram Road Ahmedabad 380009 |
| 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 = 15 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Mohan Mantri |
AKANKSHA ORTHO.HOSPITAL |
5A2, AKANKSHA ORTHO.HOSPITAL ,VIGYAN NAGAR -300045
Kota
|
9828044007;0744-2421369, 2427359
|
| Dr. Sunil Singh |
Anjali Dental Clinic, Bhopal |
Anjali Dental Clinic; Dr. SK Singh, ,341-Rachananagar, Post Govindpura,-462023
Bhopal
|
9425600200
sunil_anjali2@yahoo.com |
| Dr. Minesh Modi |
Ashakta Ashram Hospital |
ASHAKTA ASHRAM HOSPITAL, ,Rampura-
Surat
|
9426030893
drminesh@yahoo.com |
| Dr. DK Jindel |
B-51 Harimarg, Jaipur |
Malviya Nagar,-
Jaipur
|
09829213212
dineshjindel@yahoo.co.in |
| Dr Rakesh Shivhare |
CHL APPOLLO HOSPITAL |
CHL-Apollo Hospitals,,A. B. Road, Near L. I. G Triangle,-452008
Indore
|
9826680273, 0731-4072550 Ext 229
0731-2549095
madhu@chl_apollo.com |
| Dr. Shailesh Shah |
Dr. SS Surgical Hospital |
Dr. SS Surgical Hospital, Vijay Tower,,Opp. Abad Dairy, Kankaria Rd. Maninagar, -
Ahmadabad
|
9824044443
ssshec@hotmail.com |
| Dr Narendra Patidar |
Gokuldas hospital |
202 Raunak Plaza, South Tukoganj,Opposite Nath Mandir, -
Indore
|
9827039911
narendrapatidar103@yahoo.in |
| Dr Apoorva Chaudhary |
Indore |
Amit Chambers, Near Pooja Dairy,MY main road,-
Indore
|
9827247787
apoorvaneepa @yahoo.in |
| Dr. Ashok Meghwal |
JLN Medical College, Ajmer |
Aakansha, Kokil Kunj,,Pal Vichala Road, -
Ajmer
|
9829099949
|
| Dr. Pritesh Patel |
Raj Surgical Hospital |
Raj Surgical Hospital, Maruti Complex, ,Drive In Rd. Memnagar, -380056
Ahmadabad
|
9825322901
devyugpritusha@yahoo.co.in |
| Dr. Shekhar Srivastava |
Shekhar Hospital |
Manisha Market, ,Shahpura,-
Bhopal
|
09826052288,0755-2425242,2423242
drshekharbhopal@hotmail.com/shekhar_hospital@rediffmail.com |
| Dr. R K Kajala |
SP Medical College |
Deaprtment of Surgery, ,SP Medical College, -
Bikaner
|
9784642077
|
| Dr. Umesh Dutta Sharma |
Sri Krishna Hospital |
Sri Krishna Hospital, Near Bijori,Lalsoth Road -
Dausa
|
9460563903
|
| Dr. Pragnesh Shah |
Sushrut Hospital |
Sushrut Hospital, Near Baadshah Dairy, ,Mahalaxmi paanch rasta, Paldi-
Ahmadabad
|
9825251564
|
| Dr. JG Patel |
VS Hospital |
Associate professor, Department of Orthopedics, ,Seth Vadilal Sarabhai Hospital, -
Ahmadabad
|
9925038375
jyotish1974 @yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Convenient Hospitals Ltd.- Dr. Rakesh Shivhare |
Approved |
| EC Smt. NHL Municipal Medical College, Ahmedabad - Dr. Jyotish G. Patel |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Apoorva Chaudhary |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Ashok Meghwal |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. DK Jindel |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Minesh Modi |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Mohan Mantri |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Narendra Patidar |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Pragnesh Shah |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Pritesh Patel |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Shailesh Shah |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Shekhar Srivastava |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Sunil Singh |
Approved |
| Independent Ethics Committe For Research in Human Subjects, Ahmedabad - Dr. Umesh Dutta Sharma |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute painful soft tissue injury |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
IBUPROFEN |
400 mg three times a day for 7 days |
| Intervention |
IN-PHARM-002 |
80 mg three times a day for 7 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1)Patients of either sex between 18 and 60 years of age diagnosed with acute painful soft tissue injury.
(2)Subjects willing to provide written informed consent
In case of female with child bearing potential Surgically sterile or using a medically accepted means of contraception with negative serum pregnancy test |
|
| ExclusionCriteria |
| Details |
(1)Concomitant peptic ulcer, gastrointestinal bleeding and asthma.
(2)Serious heart, blood, renal or hepatic diseases.
(3)Clinically significant abnormalities on physical examination or laboratory tests.
(4)Ongoing use of prohibited medications [i.e. other NSAIDs, opioid analgesics and systemic corticosteroids].
(5)Pregnancy or lactation.
(6)As deemed inappropriate for enrollment by investigating physician due to other reasons.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| (1) Change in the visual analog scale at endpoint compared to baseline. |
At the end of treatment |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| (1)Change in investigators global assessment of pain relief at the endpoint compared to baseline. (2)Percent of patients requiring rescue medication. |
At the end of treatment
At every visit |
|
Target Sample Size
Modification(s)
|
Total Sample Size="204"
Sample Size from India="204" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
23/02/2010 |
| Date of First Enrollment (Global) |
23/02/2010 |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
Brief Summary
Modification(s)
|
This study has been undertaken to compare the efficacy and safety of IN-PHARM-002 with ibuprofen in patients with acute painful soft tissue injury. It is expected that IN-PHARM-002 would be more effective in reducing pain, safe and well tolerated in comparison to ibuprofen in the treatment of Indian patients with acute painful soft tissue injury. The trial will be conducted in 270 Indian patients of acute painful soft tissue injury within India. Patient enrolment in the study is anticipated to start on 23/02/2010. |
