| CTRI Number |
CTRI/2018/04/013316 [Registered on: 17/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of two different types of painkiller topical formulations |
|
Scientific Title of Study
|
Prospective,open-label,randomized,parallel group,comparative clinical study of two topical
formulations of diclofenac diethylamine in the treatment of acute painful musculoskeletal conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogesh Sharma |
| Designation |
Professor & HOD |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Orthopedics Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
8407958962 |
| Fax |
|
| Email |
doctoryogeshsharma@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivek mathew philip |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Orthopedics Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
7507011166 |
| Fax |
|
| Email |
vivekphilip121@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivek mathew philip |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Orthopedics Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
7507011166 |
| Fax |
|
| Email |
vivekphilip121@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College Pune |
| Address |
Armed Forces Medical College Pune Maharashtra |
| 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 |
| Vivek Mathew Philip |
Armed Forces Medical College |
Department of
Orhopedics Golden
Jubilee Block,
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
02026026019
vivekphilip121@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ARMED Forces Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from acute musculoskeletal
painful conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical gel containing diclofenac diethylamine 1.16 % w/w |
The comparator agent is used
on the other group b topically 4 times a day for 7 days and the pain relief will be measured on Day 3 and Day 7 using the Visual Analogue Score |
| Intervention |
topical solution of diclofenac
diethylamine (4.64%) |
this agent is used on patients satisfying the the inclusion criteria topically 4 times a day for 7 days and the pain relief will be measured on Day 3 and Day 7 using the Visual Analogue Score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients with acute painful musculoskeletal pain |
|
| ExclusionCriteria |
| Details |
1. All patients denying consent to participate in the trial
2. All patients with deep abrasions and lacerations around the area of affliction
3. Individuals with known adverse reaction to topical Diclofenac preparations. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity difference (PID) from baseline (before starting treatment) during movement (of affected area) and at rest |
Day 3 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Requirement of oral analgesics
2. Side effects |
Day 3 and 7 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2017 |
| Date of Study Completion (India) |
01/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Prospective,randomized, clinical trial to compare efficacy of two topical formulations of Diclofenac Diethylamine in the Treatment of Acute Painful Musculoskeletal Conditions being carried out in a tertiary care centre of Pune. Patients with acute musculo-skeletal pain (total of 140) are being randomise in to two groups and given the two above mentioned formulations. The primary and secondary objectives mentioned before are assessed using VAS and other scales as mentioned in the methodology. The measurements of the same are being carried out on Day 3 and 7 of the intervention.Results will be tabulated,statistically analysed and forwarded.
Results: Both the topical formulations of diclofenac were found to be effective and safe in management in acute painful musculoskeletal conditions when compared with baseline assessment. However, topical solution of diclofenac 4.64% w/v was superior to diclofenac topical gel 1.16% w/w in the both primary and secondary efficacy endpoints. The pain intensity difference was significantly lesser with Diclofenac topical 4.64% topical solution as compared to diclofenac topical gel 1.16% w/w on day 3 (P < 0.05) and day 7 (P < 0.05). Further, it was observed that, there was more proportion of groups B patients (22.85%) who required rescue analgesia when treated with topical diclofenac gel as compared to group A patients (1.42%) treated with Diclofenac topical 4.64% topical solution. |