| CTRI Number |
CTRI/2009/091/000799 [Registered on: 05/10/2009] |
| Last Modified On: |
10/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
To determine the efficacy and safety of topical diclofenac solution in comparison with topical diclofenac gel in acute painful musculoskeletal conditions. |
Scientific Title of Study
Modification(s)
|
A Randomized, Two Arm, Open Label, Active Controlled, Multicentric Clinical Study to Evaluate the Efficacy and Safety of a Topical Solution of Diclofenac (2.32% w/v) in comparison with Diclofenac Topical Gel (1.16% w/w) in Acute Painful Musculoskeletal Conditions. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CT/06/02 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
Vice President |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited
Commerce House- 1", Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
07926856242 |
| Fax |
07926856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
Vice President |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited
Commerce House- 1", Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
07926856242 |
| Fax |
07926856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
Vice President |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited
Commerce House- 1", Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
07926856242 |
| Fax |
07926856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Troikaa Pharmaceuticals Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Ltd.
Commerce House - 1,
Satya Marg, Bodakdev,
Ahmedabad-380 054. Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Madan Hardikar |
Hardikar Hospital |
Ganekshing Road,-411005
Pune
MAHARASHTRA |
+91-20-25535326
+91-20-25535632
hardikar@vsnl.com |
| Dr. P. S. Arul Rajamurugan |
Madurai Arthritis and Rheumatism Centre, Madurai |
Madurai Arthritis and Rheumatism Centre,,2/757, 4th East Cross Street, Anna nagar,-625020
Madurai
TAMIL NADU |
91 -9840665286
psarul1968@yahoo.co.in |
| Dr. Jatinder Juneja |
National Institute of Arthritis, New Delhi |
National Institute of Arthritis,,E-5, Bali Nagar,-110015
New Delhi
DELHI |
91 ? 9810315395
jatinderjuneja@hotmail.com |
| Dr. Anmol Maria |
Orthocare, Delhi |
Consultant Orthopedic & Joint Replacement Surgeon, Orthocare,,New Friends Colony,-110025
New Delhi
DELHI |
011-26830543
anmolmaria@gmail.com |
| Dr. Chetan V. Pradhan |
Sancheti Institute for Orthopaedics & Rehabilitation |
16, Shivaji Nagar,-411005
Pune
MAHARASHTRA |
+91-20-28999999
+91-20-28999999
pradhanchetan@hotmail.com |
| Dr Arvind Saxena |
Shanti Mukund Hospital, Delhi |
Shanti Mukund Hospital,,E-4/30, Krishna Nagar,-110051
New Delhi
DELHI |
91981034354
drarvindsaxena@hotmail.com |
| Dr. T. V. Raja |
Visa Hospital, Chennai |
Visa Hospital,,No. 27/1, South West Bong Road, T. Nagar-600017
Chennai
TAMIL NADU |
91-9841038388
drtvraja@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee, Hardikar Hospital |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad |
Approved |
| Independent Ethics Committee, Sancheti Institute for orthopaedics & Rehabilitation |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Painful Musculoskeletal Conditions, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Topical diclofenac gel (Diclofenac diethyl ammonium 1.16% w/w) |
To be applied at the site of pain 4 times a day |
| Intervention |
Topical Diclofenac solution (Diclofenac diethyl ammonium 2.32% w/v) |
To be applied at the site of pain 4 times a day |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or females patients aged 18- 70 years.
2.Patients with acute low back ache (non- specific) or pain and inflammation following trauma to muscles/ tendons/ ligaments/ joints (due to strains, sprains, stress, soft tissue injuries or blunt sports injuries) for not more than 2 days.
3.Patients with at least moderate pain of VAS greater than or equals to 4 |
|
| ExclusionCriteria |
| Details |
1.Patients below 18 years or above 70 years of age.
2.Hypersensitivity to aspirin/ NSAID or any other component of the formulation
3.Any contraindication to diclofenac / NSAIDs
4.Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application
5.Concomitant skin disease at site of application
6.Use of another topical product at application site
7.Pregnant women and lactating mothers
8.Women of child bearing age not practicing or not willing to use contraceptive
9.Unwilling patients.
10.Patients already on oral NSAIDs/ analgesics.
11.Patients requiring hospitalization or other treatment for pain. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in pain intensity from baseline, as determined by VAS (0- 10). |
At the end of day 3 and day 7 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Need for rescue analgesic |
On 3rd and 7th day. |
| Pain intensity at rest and on passive movement |
On 1st, 3rd and 7th day. |
| Degree of local signs (swelling, tenderness) |
On 1st, 3rd and 7th day. |
| Degree of functional impairment |
On 1st, 3rd and 7th day. |
| Global assessment by Physician and patients |
At the end of study (7th day) |
| No. of adverse event, No. of patients with adverse events |
On 3rd and 7th day. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="250"
Sample Size from India="250"
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
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/10/2009 |
| 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
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A topical solution formulation of diclofenac has been developed for site specific application in acute musculoskeletal conditions like trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains and strains, localized forms of soft tissue rheumatism, osteoarthritis of superficial joints such as the knee, etc. This topical formulation has been designed with a higher strength of 2.32% w/v diclofenac diethyl ammonium (equivalent to diclofenac sodium 2% w/ v), an added absorption enhancer, and is supplied in roll on bottles. The current study aims to determine the efficacy and safety of diclofenac topical solution in comparison with topical diclofenac gel in acute painful musculoskeletal conditions. |