| CTRI Number |
CTRI/2014/08/004821 [Registered on: 05/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
04/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Oxaceprol versus tramadol in knee osteoarthritis |
|
Scientific Title of Study
|
Oxaceprol versus tramadol in knee osteoarthritis: a randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parasar Ghosh |
| Designation |
Associate Professor |
| Affiliation |
Institute of Postgraduate Medical Education & Research |
| Address |
Dept. of Rheumatology
Institute of Postgraduate Medical Education & Research
244 A. J. C. Bose Road
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433988317 |
| Fax |
|
| Email |
drparasar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avijit Hazra |
| Designation |
Professor |
| Affiliation |
Institute of Postgraduate Medical Education & Research |
| Address |
Dept. of Pharmacology
UCM Building (1st floor)
Institute of Postgraduate Medical Education & Research
244 A. J. C. Bose Road
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831188172 |
| Fax |
03324764656 |
| Email |
blowfans@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kaushik Mukhopadhyay |
| Designation |
Post Graduate Trainee |
| Affiliation |
Institute of Postgraduate Medical Education & Research |
| Address |
Dept. of Pharmacology
UCM Building (1st floor)
Institute of Postgraduate Medical Education & Research
244 A. J. C. Bose Road
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9163167014 |
| Fax |
|
| Email |
dr_kaushik@ymail.com |
|
|
Source of Monetary or Material Support
|
| Lupin Pharmaceuticals, Inc. |
|
|
Primary Sponsor
|
| Name |
Institute of Postgraduate Medical Education Research |
| Address |
244 A. J. C. Bose Road
Kolkata 700020
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Kaushik Mukhopadhyay |
Institute of Postgraduate Medical Education & Research |
Rheumatology outpatient clinic
room No.5
Rheumatology building
Kolkata
WEST BENGAL |
9163167014
dr_kaushik@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMEandR Research oversight commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Primary osteoarthritis of the knee, either unilateral or bilateral, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oxaceprol |
Oxaceprol is an anti-inflammatory drug used in the treatment of osteoarthritis. It is derived from L-proline, a DNA-encoded amino acid. The active effect of Oxaceprol is to inhibit the adhesion and migration of white blood cells.
Dose: 1 capsule containing 200 mg Oxaceprol to be taken orally three times daily after
meal.
Total duration of treatment is 12 weeks. |
| Comparator Agent |
Tramadol |
Tramadol is a weak μ-opioid receptor agonist, a serotonin releaser and a reuptake inhibitor of norepinephrine.
Dose: 1 capsule containing 50 mg tramadol to be taken orally three times daily after meal.
Total duration of treatment is 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of primary symptomatic OA affecting at least one knee joint (in case of bilateral knee involvement, the more symptomatic knee will be scored as the ‘signal knee’) fulfilling the following:
• Age: Above 50 years
• Sex: Either sex will be included
• Knee joint pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min OR knee crepitus
• Knee pain on movement of intensity at least 35 mm on a 100 mm VAS (Visual Analogue Score) scale.
|
|
| ExclusionCriteria |
| Details |
• Secondary OA, such as due to injury, inflammatory condition, metabolic or rheumatic disease, osteonecrosis, Paget’s disease, hemophilia etc.
• Non-OA causes of knee pain in the signal knee (e.g. bursitis, fibromyalgia, osteonecrosis etc)
• Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months.
• Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrollment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at anytime.
• Severe and advanced OA disease, defined as joint space width 2 mm or deformed joint, or disease necessitating knee surgery in the current year.
• Serious concomitant disease.
• Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, is not conducive to enrollment of a particular subject into the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of oxaceprol in symptomatic primary osteoarthritis of the knee |
Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety profile of Oxaceprol |
Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/10/2013 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we propose to evaluate the effectiveness and safety of Oxaceprol (200 mg thrice daily orally) as analgesic in osteoarthritis of the knee in comparison to Tramadol (50 mg thrice daily orally) in a randomized single blind controlled trial design. Study population would be patients attending Rheumatology OPD of IPGME&R & SSKM Hospital, Kolkata. Target sample size will be 50 evaluable patients in each group (assuming dropout rate 20%), suffering from primary symptomatic knee osteoarthritis. Subjects with secondary forms of osteoarthritis, history of recent invasive intervention of the knee, severe form of the disease or significant comorbidity would be excluded. After obtaining written informed consent, subjects would be observed for 1 week without any drug. At the end of 1 week, they would be randomly allocated to oxaceprol or tramadol and treatment continued for 12 weeks. Interim follow-up visits would be at 4 week intervals. Patients will be assessed by WOMAC osteoarthritis index and a 5-point clinical global impression (CGI) scale. A responder rate will be calculated on basis of 50% reduction in pain score. We would also look for treatment emergent adverse events and effects on standard laboratory safety parameters. |