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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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