CTRI Number |
CTRI/2013/05/003618 [Registered on: 07/05/2013] Trial Registered Retrospectively |
Last Modified On: |
07/05/2013 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A study to evaluate cost effectiveness and safety of pain killers with and without acid reducing drugs in patients having pain in knee. |
Scientific Title of Study
|
A comparative study to evaluate efficacy,safety and cost effectiveness between Tramadol and Diclofenac with and without proton pump inhibitor in patients with knee osteoarthritis. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mrs YogitaSurendraKarandikar |
Designation |
Lecturer |
Affiliation |
B.V.U.Medical College, Dhankawadi, Pune |
Address |
Dept. of Pharmacology
Address: Work – B.V.U.Medical College, Dhankawadi, Pune – 411 043
Residence - 3, Nayananandsociety,AnandnagarSinhgad road Pune
Telephone- (020) 24357401(R) Pune MAHARASHTRA 411 043 India |
Phone |
9922747908 |
Fax |
|
Email |
karandikar_yogita@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mrs YogitaSurendraKarandikar |
Designation |
Lecturer |
Affiliation |
B.V.U.Medical College, Dhankawadi, Pune |
Address |
Dept. of Pharmacology
Address: Work – B.V.U.Medical College, Dhankawadi, Pune – 411 043
Residence - 3, Nayananandsociety,AnandnagarSinhgad road Pune
Telephone- (020) 24357401(R) Pune MAHARASHTRA 411 043 India |
Phone |
9922747908 |
Fax |
|
Email |
karandikar_yogita@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
DrMehwishmajeed |
Designation |
Resident in Pharmacology |
Affiliation |
B.V.U.Medical College and Hospital |
Address |
Room705 ,new pg hostel
B.V.U.Medical College and Hospital , Dhankawadi, Pune – 411 043
Pune MAHARASHTRA 411 043 India |
Phone |
875873740 |
Fax |
|
Email |
mehwishmajeed@rocketmail.com |
|
Source of Monetary or Material Support
|
Department of Orthopedics
Bharati Hospital , Dhankawadi, Pune – 411 043
|
|
Primary Sponsor
|
Name |
DrMehwishmajeed |
Address |
Dept. of Pharmacology
B.V.U.Medical College and Hospital, Dhankawadi, Pune – 411043 |
Type of Sponsor |
Other [Dr.Mehwishmajeed -investigator initiated trials] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Mehwishmajeed |
Department of Orthopedics Bharati Hospital , |
BharatiVidyapeeth Deemed University Medical College, and Hospital , Dhankawadi, Pune – 411 043 Pune MAHARASHTRA |
875873740
mehwishmajeed@rocketmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee,B.V.D.U Medical college,Pune-43 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
knee osteoartharitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Diclofenac and Famotidine |
Diclofenac(100mg SR OD)and H2 blocker( Famotidine 20 mg)orally for 2 wks |
Intervention |
Diclofenac and Omeprazole |
Diclofenac(100mg SR OD)and PPI(Omeprazole 20mg)orally for 2 wks |
Comparator Agent |
Tramadol |
Tramadol (200mg SR OD)orally for 2 wks, |
Intervention |
Tramadol and Omeprazole |
Tramadol (200mg SR OD)and PPI (Omeprazole 20mg)for 2 wks orally |
|
Inclusion Criteria
|
Age From |
45.00 Year(s) |
Age To |
85.00 Year(s) |
Gender |
Both |
Details |
1. Patients’ aged 45 years or older of either sex.
2. Patients consulting for non-traumatic knee pain/primary symptomatic knee OA.
3. Complying to the clinical American College of Rheumatology (ACR) criteria for osteoarthritis of the knee.
4. A score of 3 or more on the pain severity scale (0-10 scale).
5. Patient willing to provide informed written consent
|
|
ExclusionCriteria |
Details |
. Contra-indication for NSAID or Paracetamol use (these are: Gastrointestinal bleedings in history or active peptic ulcer, serious liver or kidney disease (glomerular filtration less than 30 ml/min),
2. An arthroplasty or osteotomy of the knee.
3. Surgery or major trauma of the affected joint within the previous 6 months
4.Pregnancy and lactating women.
5.Patients who were treated with corticosteroid and hyaluronic injection to the target joint within two months prior to the study medication administration.
6. Patient having osteoarthritisfor more than 5 years.
7.Patients with Rheumatoid arthritis, Ankylosing spondylitis, Active gout or active pseudo-gout.
8.Patients advised physiotherapy
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1 KOOS questionnaire:The Knee injury and Osteoarthritis Outcome Score
2.Efficacy by VAS(Visual analogue score) questionnaire
3.Cost effective analysis between Tramadol and diclofenac
4.adverse effects of Tramadol and Diclofenac |
2 and 4 wks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. relation between demographic profile of patients and knee osteoarthritis
2.The quality of life of osteoarthritis patients by KOOS
4. To compare cost effectiveness of Diclofenac with H2 blocker or PPI
|
2 and 4 wks
|
|
Target Sample Size
|
Total Sample Size="94" Sample Size from India="94"
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 4 |
Date of First Enrollment (India)
|
04/02/2013 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Arthritic pain is common and is associated with
worst functional outcome and poorer quality of life. Most commonly used drug in
clinical practice is Tramadol and Diclofenac. Routinely NSAIDS are given along
with PPI.In addition to anti-secretory effects, however, PPIs have shown anti-inflammatory
effects . But the role of PPIs as anti-inflammatory agents in addition to acid
lowering property in osteoartharitis and
cost effectiveness remains to be explored. In developing countries it is very
important to assess what drugs may decrease the subsequent use of medical care
resources considering their adverse events that are known to have a significant
increase in medical care costs of patients with osteoarthritis..Keeping the above limitations in
mind we have designed a study to evaluate cost effectiveness and safety between
two most commonly used drugs.
This study is a randomized, active control, parallel group, single centre comparative study to evaluate cost effectiveness and safety between Tramadol(200mg SR OD) and Diclofenac(100mg SR OD) with and without proton pump inhibitor(omeprazole 20 mg) in 94 patients with knee osteoarthritis.Drugs will be given for two weeks and if necessary drug will be continued with rescue medication given for 2 more wks. The primary outcome measures will be by KOOS questionnaire:The Knee injury and Osteoarthritis Outcome Score, and pain assessment by Visual analouge scale at 2 and 4 wks.Cost effectiveness ratio for different groups will be calculated by dividing the cost of treatment by its clinical outcome to yield the ratio in terms of rupees. Adverse events spontaneously reported by patients and adverse events observed by the investigator will be recorded at each visit. |