| CTRI Number |
CTRI/2011/091/000150 [Registered on: 01/02/2011] |
| Last Modified On: |
15/03/2011 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
Clinical trial to evaluate the efficacy and safety of the fixed dose combination of Tramadol 50 mg IR + Diclofenac 75 mg SR vs fixed dose combination of Tramadol 37.5 mg + Paracetamol 325 mg in treatment of patients with moderate to severe pain due to acute musculoskeletal conditions , acute flare of osteoarthritis , acute flare of rheumatoid arthritis and post operative pain |
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Scientific Title of Study
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A Randomized, open labeled, comparative , parallel group, multicentric trial to evaluate the efficacy and safety of the proposed fixed dose combination of Tramadol 50 mg IR + Diclofenac 75 mg SR vs standard / approved fixed dose combination of Tramadol 37.5 mg + Paracetamol 325 mg in treatment of patients with moderate to severe pain due to acute musculoskeletal conditions , acute flare of osteoarthritis , acute flare of rheumatoid arthritis and post operative pain |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| PHL/03/09, Version 1; dated 04/03/09 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Ajay Chandanwale |
| Designation |
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| Affiliation |
|
| Address |
Head Department of Orthopedics
Sir J.J group of Hospitals
Mumbai
MAHARASHTRA
400008
India |
| Phone |
022-23735555 |
| Fax |
|
| Email |
drasc62@rediffmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr.Manoj Naik |
| Designation |
|
| Affiliation |
Chief Manager |
| Address |
Abbott Healthcare Private Limited
D-Mart Building, Goregaon Mulund Link Road, Mulund(W)
Mumbai
MAHARASHTRA
400080
India |
| Phone |
022-39536910 |
| Fax |
022-39536665 |
| Email |
manoj.naik@piramal.com |
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Details of Contact Person
Public Query
|
| Name |
Manoj.M.Prabhu |
| Designation |
|
| Affiliation |
|
| Address |
Abbott Healthcare Private Limited
D-Mart Building, Goregaon Mulund Link Road,Mulund(W)
Mumbai
MAHARASHTRA
400080
India |
| Phone |
022-39536910 |
| Fax |
022-39536665 |
| Email |
manoj.prabhu@piramal.com |
|
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Source of Monetary or Material Support
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| Abbott Healthcare Private Limited
D-Mart Building
Goregaon Mulund Link Road
Mulund(W)
Mumbai- 400080 |
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Primary Sponsor
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| Name |
Abbott Healthcare Private Limited, Mumbai |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Ajay Chandanwale |
Grant Medical College & Sir J.J Group of Hospitals |
Head Department of Orthopedics,Byculla-400008
Mumbai
MAHARASHTRA |
022-23735555
drasc62@rediffmail.com |
| Dr.Sundar Subramanian |
V.S.Hospital |
Consultant Orthopedician,13, East Spurtank Road, Chetpet-600031
Chennai
TAMIL NADU |
044-42001000
044-28191021
drsundar69@hotmail.com |
| Dr.K.Latchoumibady |
Vijay Hospital |
Consultant Orthopedician,ECR Byepass, Lawspet-8
Pondicherry
PONDICHERRY |
0413-2342342
latchoumibady@yahoo.co.in |
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Details of Ethics Committee
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| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Commitee- V.S Hospital, Chennai |
Approved |
| Ethics Commitee- Vijay Hospital, Pondicherry |
Approved |
| Institutional Ethics Commitee , Grant Medical College & Sir J.J Group of Hospitals, Byculla, Mumbai |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Moderate to severe pain due to acute musculoskeletol conditions, acute flare of osteoarthritis, acute flare of rhematoid arthritisand post operative pain, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Tramadol 50 mg IR + Diclofenac 75 mg SR |
2 Tablets daily for 5 days |
| Comparator Agent |
Tramadol 37.5 mg + Paracetamol 325 mg |
2 tablets every 4 to 6 hours , upto maximum of eight tablets per day for 5 days |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1.Males and females aged above 18 years and less than 70 years (women of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as IUD, contraceptive pill or depot gestagen) throughout the study).
2.Clinical diagnosis of acute musculoskeletal pain (tendinitis, Bursitis, synovitis) acute flare of osteoarthritis, acute flare of Rheumatoid arthritis and post operative pain
3.Subjects with moderate pain confirmed by a VAS Score > 50 mm in the scale during the last 5 days prior to the Baseline Visit. (In post operative pain only those subjects will be screened who can take oral medications)
4.Subjects must be willing to discontinue all other analgesics / existing analgesic treatment.
5.Subjects willing to give informed consent.
6.Subjects willing to fill patient diary cards/ patient assessment forms and comply with the study procedure and requirements.
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| ExclusionCriteria |
| Details |
1.Pregnant and nursing women
2.Patients hypersensitive to Tramadol, Diclofenac and paracetamol .
3.Subjects previously discontinued from tramadol, diclofenac and paracetamol therapy due to adverse effects
4.Subjects had undergone therapy with Tramadol within 30 days before study entry.
5.Subjects had received antidepressants therapy within 4 weeks of study entry.
6.Subjects diagnosed with fibromyalgia, active peptic ulcer , GI tract bleeding.
7.Subjects also with the history of peptic ulcers, gastric irritations and NSAIDs intolerance
8.Subjects with abnormal renal and liver function parameters
9.Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine for the pain.
10.Ancillary physiotherapy massage or physical therapy within 48 hours.
11.Subjects had acupuncture within 3 weeks of study entry.
12.Subjects treated with intra- articular injection of corticosteroids within two months.
13.History of chronic condition(s) (expect OA & RA) , requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout) and severe respiratory disease.
14.Subjects with history of abnormal / impaired creatinine clearance .
15.Substance or alcohol abuse, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behavior.
16.Untreated depression or other psychiatric disorder in such a way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
17.Subject with a history of attempted suicide or substance abuse.
18.Subjects, who are unsuitable for any other reason to participate in the study in the opinion of the Investigator.
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 1. Reduction in pain intensity from baseline to all visits.
2. Pain relief at the end of the study
|
Baseline, Day 3 and Day 5 |
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Secondary Outcome
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| Outcome |
TimePoints |
| 1. Disability score measurement from baseline to all visits
2. Reduction in swelling and inflammation from baseline to all the visits
3. Use of rescue medication
4. Safety parameters
5. Global assessment for efficacy and tolerability
|
Baseline, Day 3 and Day 5 |
|
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
12/10/2010 |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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A Randomized, open labeled, comparative , parallel group, multicentric trial to evaluate the efficacy and safety of the proposed fixed dose combination of Tramadol 50 mg IR + Diclofenac 75 mg SR vs standard / approved fixed dose combination of Tramadol 37.5 mg + Paracetamol 325 mg in treatment of patients with moderate to severe pain due to acute musculoskeletal conditions , acute flare of osteoarthritis , acute flare of rheumatoid arthritis and post operative pain.
The study will be conducted at 3 centres in India only.
200 patients satisfying the Inclusion / Exclusion criteria will be enrolled in the trail and will recieve either of the two treatments as per randomization chart and will be followed up for 5 days to analyse the pain relief and reduction in pain intensity at end of 5 days treatment.
Patient FPFV (First Patient First Visit) was 12th Oct 2010. |