| CTRI Number |
CTRI/2012/12/003263 [Registered on: 26/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
11/12/2012 |
| 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 Diclofenac in Lipogel in Comparison to Emulgel and Placebo in Patients with Signs and Symptoms of Osteoarthritis of the Hip, Knees and Hands. |
|
Scientific Title of Study
|
A Single Centre Randomized, Double-Blind, Short-Term Trial for Evaluation of the Efficacy and Safety of Topically Applied Diclofenac in Lipogel in Comparison to Diclofenac in Emulgel and Placebo in Patients with Signs and Symptoms of Osteoarthritis of the Hip, Knees and Hands. |
| Trial Acronym |
SCRDDO |
|
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 |
PGIMER |
| Address |
Department of Orthopaedic Surgery
Post Graduate Institute of Medical Education & Research (PGIMER) Chandigarh
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 |
| Address |
University Institute of Pharmaceutical Sciences
Panjab University
Chandigarh
CHANDIGARH
160014
India |
| Phone |
01722534112 |
| Fax |
0172-2534101 |
| Email |
drkatare@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Amit Bhatia |
| Designation |
Assistant Professor |
| Affiliation |
University Institute of Pharmaceutical Sciences |
| Address |
University Institute of Pharmaceutical Sciences
Panjab University
Chandigarh
CHANDIGARH
160014
India |
| Phone |
01722534112 |
| Fax |
0172-2534101 |
| Email |
amitbhatia_pu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| University Institute of Pharmaceutical Sciences
Basic Medical Sciences Block
Panjab University, Chandigarh 160014 |
|
|
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
|
|
|
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 |
1722756747
vijaygoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee of Post Graduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoarthritis of the Hip, Knees and/or Hands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diclofenac lipogel |
TID, Topical for 6 weeks |
| Comparator Agent |
Emulgel |
TID, Topical for 6 weeks |
| Comparator Agent |
Placebo |
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 OA 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. Demonstrated x-ray evidence of osteoarthritis in the most involved areas during the last six months
7. Patient who also met 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.
8. 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. Opioid 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="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/01/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 evaluation of the safety and efficacy of a novel gel formulation of Diclofenac 1% w/w in patients with signs and symptoms of osteoarthritis of the knees.
Thirty six patients with knee osteoarthritis were treated (randomized) with 1% w/w diclofenac topical novel gel or marketed gel or placebo gel (negative control), for a period of 6-weeks (evaluations were done on 1, 2, 4 & 6 week). Efficacy outcome measure selected was the change from baseline to end of study on the WOMAC (i.e., Westren Ontario and McMaster Universities) OA index of pain, stiffness and physical function having scores on 5-point Likert scale. Other safety and efficacy measures selected were change in swelling, adverse effect, dermal-irritation scores, changes in vital signs of the patient obtained at each visit. In the current clinical study, patients of all the groups, showed a positive response to the novel topical formulations of Diclofenac vis-Ã -vis placebo at the end of treatment.
Diclofenac novel gel 1%w/w, however, was found to be more effective in comparison to marketed formulation of diclofenac at equivalent drug concentration. With respect to safety, all the tested formulations were found to be safe, as no dermal as well as GI adverse event was recorded during study.
The results of phamacodynamic along with other safety evaluation protocols followed in the current investigations clearly indicated the superiority of the novel gel formulation of diclofenac. |