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CTRI Number  CTRI/2012/12/003167 [Registered on: 03/12/2012] Trial Registered Prospectively
Last Modified On: 03/12/2012
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effects of topical etodolac in lipogel in patients with Signs and Symptoms of Osteoarthritis of the Hip, Knee and Hand. 
Scientific Title of Study   A Single Centre Randomized, Double-Blind, Short-Term Trial for Evaluation of the Efficacy and Safety of Topically Applied Etodolac in Lipogel in Comparison to Volini gel and Placebo in Patients with Signs and Symptoms of Osteoarthritis of the Hip, Knee and Hand. 
Trial Acronym  SCRETO 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijay G Goni 
Designation  Additional Professor 
Affiliation  Department of Orthopaedic Surgery Post Graduate Institute of Medical Education & Research 
Address  Department of Orthopaedic Surgery Post Graduate Institute of Medical Education & Research (PGIMER) Chandigarh India Chandigarh CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  1722756747  
Fax  1722740909  
Email  vijaygoni@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr O P Katare 
Designation  Professor  
Affiliation  University Institute of Pharmaceutical Sciences Panjab University 
Address  University Institute of Pharmaceutical Sciences Panjab University Chandigarh CHANDIGARH 160014 India

Chandigarh
CHANDIGARH
160014
India 
Phone  01722534112  
Fax  01722534101  
Email  drkatare@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Mr Kaisar Raza 
Designation  Senior Research Fellow 
Affiliation  University Institute of Pharmaceutical Sciences Panjab University 
Address  University Institute of Pharmaceutical Sciences Panjab University Chandigarh CHANDIGARH 160014 India

Chandigarh
CHANDIGARH
160014
India 
Phone  01722534112  
Fax  01722534101  
Email  razakaisar_pharma@yahoo.co.in  
 
Source of Monetary or Material Support  
University Institute of Pharmaceutical Sciences 
 
Primary Sponsor  
Name  University Institute of Pharmaceutical Sciences 
Address  University Institute of Pharmaceutical Sciences Basic Medical Sciences Block Panjab University, Chandigarh 160014 
Type of Sponsor  Other [Academic and Research Institute] 
 
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 Vijay G Goni  New OPD, Department of Orthopedic Surgery, PGIMER  Post Graduate Institute of Medical Education and Research, Sector- 12, Chandigarh- 160 012 Chandigarh CHANDIGARH
Chandigarh
CHANDIGARH 		 1722756747

vijaygoni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe[PGIMER]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoarthritis of the Hip, Knee and Hand,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Etodolac gel  TID, Topical for 6 weeks  
Comparator Agent  Placebo  TID, Topical for 6 weeks 
Comparator Agent  Volini gel  TID, Topical for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female of age ≥ 18.
2. Must be in generally good health as confirmed by medical and previous medication history, and baseline physical examination including vital signs.
3. Symptomatic osteoarthritis of the target hip or knee joint as evidenced by hip or knee pain for at least 3 months (for at least 20 days of each month) and osteophytes confirmed by an x-ray taken within the last two years
4. After a full explanation of the study, subjects must understand the nature of the study and sign the informed consent form to participate.
5. Patients must have osteoarthritis of knees, hip and hands for a minimum of six months - have moderate pain in the most involved area when not taking non-steroidal anti-inflammatory drugs (NSAIDs).
6. Demonstrate x-ray evidence of osteoarthritis in the most involved areas during the preceding six months
Patient who also meet two of the following three clinical criteria:
a) Morning stiffness of, 30 minutes duration, crepitus on motion.
b) Rating their pain in the index knee as >3 on a five-point Likert scale.
c) Taking oral NSAIDs at least 3 days per week for the past 3 months or for >25 of the past 30 days.
Moreover, patients had to meet three osteoarthritis flare criteria:
a) Pain in the index knee on walking >40 mm on a visual analogue scale (VAS).
b) Increased by >15 mm compared with pain on pre-study treatment (screening).
c) Patient global assessment (PGA) score for osteoarthritis of 3–5 and at least one grade increase from screening. 
 
ExclusionCriteria 
Details  1. Patient receiving physical therapy to either knee or having a history of allergy, hypersensitivity or contraindication to NSAID.
2. Pregnant or lactating females
3. Open wounds, infected skin or fractures
4. Opiod use within 7 days
5. Prior topical medication applied to the painful region/area of study
6. Subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain (e.g. arthroscopic techniques, osteotomy, joint replacement surgery, etc.).
7. Subjects who are experiencing another type of continuous pain that is more severe in intensity in comparison with the OA target joint pain (e.g. low back pain, fibromyalgia, ankylosing spondylitis, etc.).
8. Subjects with a significant psychiatric disorder (including major depression) or subjects receiving anti-psychotic medication.
9. Subjects who have taken sedatives, hypnotics, phenothiazines, anticonvulsants, tranquilizers or muscle relaxants two weeks preceeding study entry. These medications cannot be started during the study.
10. Subjects with documented or suspected history of alcohol or drug abuse, or who have a documented or suspected history of an addictive personality.
11. Have a history of partial or total knee replacement in either knee, or have a history of gout, pseudo-gout induced synovitis, or infection of the more severe knee 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean fall in five point scale of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index from the baseline  0, 1, 2, 4, 6 week 
 
Secondary Outcome  
Outcome  TimePoints 
Mean fall in five point scale of Patient Global Assessment from the baseline  0, 1, 2, 4, 6 week 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2 
Date of First Enrollment (India)   03/12/2012 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study is a single centric randomized, double-blind trial for the evaluation of safety and efficacy of a novel gel formulation of etodolac 2% w/w in patients with signs and symptoms ofosteoarthritis of hip, knee and hand.

Seventy patients with knee osteoarthritis will be treated (randomized) with 2% w/w etodolac topical gel or marketed gel or placebogel (negative control), for a period of 6-weeks (evaluations were doneon 1, 2, 4 & 6 week). Efficacy outcome measure will be thechange from baseline to end of study on the WOMAC (i.e., WestrenOntario and McMaster Universities) OA index of pain, stiffness andphysical function having scores on 5-point Likert scale. Other safetyand efficacy measures selected will be change in swelling, adverseeffect, dermal-irritation scores, changes in vital signs of the patientobtained at each visit.

The outcomes will be compared and statistically analyzed for any significant difference in the efficacy of the etodolac gel vis-à-vis marketed product and the placebo gel.

 
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