| CTRI Number |
CTRI/2010/091/000081 [Registered on: 12/04/2010] |
| Last Modified On: |
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| 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, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effects of a fixed dose combination of two drugs Diacerein + Aceclofenac and aceclofenac on patients with osteoarthritis |
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Scientific Title of Study
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Comparative Assessment Of The Efficacy, Safety And Tolerability Of Fixed Dose Combination Of Diacerein Plus Aceclofenac With Aceclofenac In Adult Patients With Osteoarthritis Of The Knee |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| 009/07;Version:GL/CAADOK /07 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr Chandrashekhar Bolmall |
| Designation |
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| Affiliation |
Medical Services |
| Address |
Glenmark Pharmaceuticals Ltd. Glenmark House
B D Sawant Marg, Chakala, Andheri(East)
Mumbai
MAHARASHTRA
400099
India |
| Phone |
91-22-40189999 |
| Fax |
91-22-401989990 |
| Email |
chandrashekharb@glenmarkpharma.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekhar Bolmall |
| Designation |
|
| Affiliation |
|
| Address |
Glenmark Pharmaceuticals Ltd. Glenmark House
B D Sawant Marg, Chakala, Andheri(East)
Mumbai
MAHARASHTRA
400099
India |
| Phone |
91-22-40189999 |
| Fax |
91-22-401989990 |
| Email |
chandrashekharb@glenmarkpharma.com |
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Source of Monetary or Material Support
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| Glenmark Pharmaceuticals Ltd |
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Primary Sponsor
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| Name |
Glenmark Pharmaceuticals Ltd |
| 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 = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr H B Shivakumar |
Ashwini Hospital |
B B Road,Yelahanka-560029
|
91-9845009961
ubsk_67@rediffmail.com |
| Dr Latchoumibady |
East Coast Hospital |
90 Thiruvallular Salai,-605013
Pondicherry
PONDICHERRY |
09443376050
latchoumibady@yahoo.co.in |
| Dr Sanjay Jagtap |
Grant Medical College and Sir J J Hospital |
Department of Orthopedics, Sir J J Road,-400008
Mumbai
MAHARASHTRA |
91-9892265018
drjagtapsanjay165@gmail.com |
| Dr A S Ramasamy |
Krishna Hospital |
MG/Chittor Cross Road, -682011
|
09846333544
ram2268@gmail.com |
| Dr K J Mathiazhagan |
M R Hospital |
Govindan Street, Ayyavoo Colony,Aminikarai, -600029
Chennai
TAMIL NADU |
91-9841040433
profkjm@rediffmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ashwini Hospital |
Approved |
| East Coast Hospitals |
Approved |
| Institutional Ethics Committee, Grant Medical College and Sir J J Hospital |
Approved |
| Krishna Hospital |
Approved |
| MR Hospital |
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 |
Osteoarthritis Of The Knee, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Aceclofenac 100 mg |
One tablet twice daily after meals |
| Intervention |
Diacerein 50 mg plus aceclofenac 100 mg |
One tablet twice daily after meals for 6 weeks |
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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 |
Males and non-pregnant females (with negative beta-human chorionic gonadotropin test). Female patients on adequate contraceptive control;Age: 30 to 70 years;Clinical and radiological diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) Clinical Classification Criteria; Patients with a baseline Patient's Assessment of Arthritis Pain-VAS score of > 40mm / 4cm, and both Patient's and Physicians' Global Assessment of Arthritis of poor or very poor; Patient willing to comply with study procedures and requirements. |
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| ExclusionCriteria |
| Details |
Pregnant and nursing women;Patients hypersensitive to any study medications and ingredients;Inflammatory arthritis, gout, pseudogout, Paget's disease or any chronic pain syndrome that may interfere with assessment of the Index hip and/or knee; Symptomatic bursitis or acute joint trauma of the Index hip and/or knee;Conditions predisposing to gastrointestinal dysfunction (eg, history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent corticosteroids; alcohol abuse; etc.),History of bleeding tendencies, cirrhosis and esophageal varices;History of hypersensitivity or allergy to NSAIDs, other COX-2 inhibitors and/or sulphonamides;Pre-existing asthma;Patients who would require concomitant therapy with drugs e.g. low dose aspirin, warfarin, anti-epileptics, fluconazole (inhibitor of CYP 2C9/3A4), ketoconazole (a known inhibitor of CYP 3A4) etc.;Immunocompromised states and patients with systemic infections;Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, collagen disorders, etc. or any other serious medical illness;Patients who have participated in a new drug study in the past 3 months;Any other condition that in the opinion of the investigator does not justify the patient's participation in the study. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Improvement in
-Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function).
-Visual Analog Scale (VAS) scores (for pain)
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Baseline, Weeks 2, 4 and 6 |
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Secondary Outcome
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| Outcome |
TimePoints |
| Improvement in Patient?s and Physician?s Global Assessment of Arthritis. |
Baseline, Weeks 2, 4 and 6 |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="8"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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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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Objective: The aim of this study was to compare the effectiveness and tolerability of a fixed ?dose combination (FDC) of diacerein 50 mg + aceclofenac 100 mg BID and aceclofenac 100 mg BID in adult Indian patients with Osteoarthritis(OA) of the knee.
Methods: This 6-week, double-blind, randomized, comparative, multicenter study was undertaken to compare oral diacerein +aceclofenac and aceclofenac alone in patients with OA after obtaining their informed consent. Participants completed the WOMAC-OA, WOMAC ?CI (for pain, stiffness, and physical function), and a visual analog scale (VAS) at each study visit. The primary end points were the WOMAC-OA, the WOMAC -CI, and VAS scores for pain among the patients who completed the study. The fixed ?dose combination of diacerein + aceclofenac was better than aceclofenac in effectiveness
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