| CTRI Number |
CTRI/2022/03/041507 [Registered on: 30/03/2022] Trial Registered Prospectively |
| Last Modified On: |
23/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Evaluate Efficacy And Safety of Aceclofenac Combination Topical Ointment in Comparison to Reference Product HIFENAC GEL® in Management of Acute Pain in Musculoskeletal Conditions. |
|
Scientific Title of Study
|
A Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study To Evaluate The Efficacy And Safety of Aceclofenac Combination Topical Ointment 1.5% w/w with HIFENAC GEL® 1.5% w/w For The Management of Acute Pain in Musculoskeletal Conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: PBL/20/03/ACEC ; Version: 03 dated : 26-03-21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
Vice President- Clinical Research |
| Affiliation |
Panacea Biotec Pharma Ltd |
| Address |
Panacea Biotec Limited
Clinical Research Department B-1 Extn/G-3,
Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044
South
DELHI
110044
India |
| Phone |
|
| Fax |
|
| Email |
lalitendumohanty@panaceabiotec.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
Vice President- Clinical Research |
| Affiliation |
Panacea Biotec Pharma Ltd |
| Address |
Panacea Biotec Limited
Clinical Research Department B-1 Extn/G-3,
Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044
DELHI
110044
India |
| Phone |
|
| Fax |
|
| Email |
lalitendumohanty@panaceabiotec.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
Vice President- Clinical Research |
| Affiliation |
Panacea Biotec Pharma Ltd |
| Address |
Panacea Biotec Limited
Clinical Research Department B-1 Extn/G-3,
Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044
DELHI
110044
India |
| Phone |
|
| Fax |
|
| Email |
lalitendumohanty@panaceabiotec.com |
|
|
Source of Monetary or Material Support
|
| Panacea Biotec Pharma Ltd
B 1 Ext./A-27, Mohan Co-operative Industrial Estate, Mathura Road,
New Delhi-110044 |
|
|
Primary Sponsor
|
| Name |
Panacea Biotec Pharma Ltd |
| Address |
B 1 Ext./A-27, Mohan Co-operative Industrial Estate, Mathura Road,
New Delhi-110044 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anup Kumar |
All India Institute of Medical Sciences |
Department of Orthopedics, AIIMS, Aurangabad Road, Phulwari Sharif, Patna- 801507, Bihar
Patna
BIHAR |
7880668537
dranupkumarcr@gmail.com |
| Dr Amit Y Pingat |
Jeevan Rekha Hospital |
Department of
Orthopedics, Ground
floor OPD, Dr B. R. Ambedkar Road, Belagavi-590002,Karnataka
Belgaum
KARNATAKA |
7880668537
dr.amitpingat@gmail.com |
| Dr V S Sharma |
Prakhar Hospital Pvt Ltd |
Room No.3, Ground
floor, 8/219, Arya Nagar, Kanpur-208002, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH |
8448522450
dr.vijaishankersharma@gmail.com |
| Dr Ajeet Pratap Singh |
Rana Hospital Pvt Ltd. |
Room No. 6, Ground
floor OPD,Rail Vihar Medical college road, Chargava, Gorakhpur, 273001, Uttar Pradesh
Gorakhpur
UTTAR PRADESH |
7652456810
ajeetpsingh1177@gmail.com |
| Dr C P Pal |
S. N. Medical College |
Department of Orthopedics, 5th floor,S N Medical College,
Raja Mandi, Near Agra College-Agra-Uttar Pradesh-282003
Agra
UTTAR PRADESH |
9634031500
drcportho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee, Prakhar Hospital |
Approved |
| IEC-AIIMS-PATNA |
Submittted/Under Review |
| Institutional Ethics Committee Jeevan Rekha Hospital |
Approved |
| Institutional Ethics Committee Rana Hospital |
Approved |
| Institutional Ethics Committee S N Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aceclofenac IP 1.5 % w/w, Linseed oil(containing predominantly α Linolenic acid 3 % w/w, methyl salicylate IP 10 % w/w, capsaicin USP 0.01 % w/w, menthol IP 5 % w/w, Benzyl alcohol IP (as preservative) 1% w/w, Base q.s,. |
Subjects will have to apply 2 gm of study treatment topically to the affected area 2 times daily for 8 days |
| Comparator Agent |
HIFENAC Gel® : Aceclofenac IP 1.5 % w/w, Oleum lini (containing predominantly alpha-linoleic acid 3 % w/w, Methyl salicylate IP 10 % w/w, Capsaicin USP 0.01 % w/w, Menthol IP 5 % w/w, Benzyl alcohol IP (as preservative) 1% w/w, Base q.s |
Subjects will have to apply 2 gm of study treatment topically to the affected area 2 times daily for 8 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or non-pregnant female patients aged between 18-65 years with a clinical diagnosis of acute pain in musculoskeletal conditions.
2.Patients with single site painful acute musculoskeletal conditions (tendinitis, bursitis, myalgia, low back-ache, sprains, pulled muscle, soft tissue injury etc.) sustained within 48 hours of screening (not requiring surgical treatment).
3.Patients with at least moderate pain at rest of Numeric rating Scale (NRS) greater or equal to 4.
4.Patient is able to provide written informed consent prior to study.
5.Willingness to comply with the study schedule and procedures.
6.If female, patient must be either postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing the following methods of birth control:
a) Oral Contraceptives or Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
b) Double Barrier methods containing or used in conjunction with a spermicidal agent, or
c) Contraceptive Patches/ Implants, or
d) Abstinence: Subjects who will be practicing abstinence will agree to have an acceptable method of birth control if the subject becomes sexually active during the course of her study participation.
7. All male subjects must agree to use accepted methods of birth control with their partners during the study. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD.
|
|
| ExclusionCriteria |
| Details |
1. Patients with any condition which in opinion of the investigator
makes the patient unsuitable for inclusion.
2. Patients with painful muscle spasms associated with
musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
3. Patient with history of osteoarthritis / rheumatoid arthritis.
4. Patients with skin wounds, open injuries or other conditions of
broken skin at the site of proposed application.
5. Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study screening.
6. Patients with history of severe cardiac, hepatic, gastrointestinal,
renal, pulmonary and skin diseases.
7. Known hypersensitivity to Aceclofenac or any other
ingredient of product or to rescue medication acetaminophen (Paracetamol).
8. Patient is a female who is pregnant or willing to get pregnant, not
ready to use contraceptive measures during the trial period or breast feeding.
9. Participation in any other clinical trial during last 90 days.
10. History of regular fever, headaches which warrants frequent use of acetaminophen (Paracetamol) or NSAIDS
11. Elevated transaminases (≥ 3 times ULN) and hemoglobin < 9.0 g/dl at screening.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy end point pertaining to Pain intensity at rest (Based on NRS) will be assessed by comparing Pain intensity (at rest) in both the arms. |
[Time frame: Baseline (day o) to day 8] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Overall clinical response based on 50% relief in patient pain.
2. Pain intensity at rest (Based on NRS).
3. Pain intensity on passive movement (Based on NRS)
4. Physicians & Patient Global Assessment Scale.
5. Need for rescue medication
6. Safety assessment |
Baseline to day 4 & day 8.
Baseline to day 4.
Baseline to day 4 & day 8.
Baseline to day 4 & day 8.
Baseline to day 4 & day 8.
Baseline to day 4 & day 8.
|
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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 3 |
|
Date of First Enrollment (India)
|
30/03/2022 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aceclofenac
is frequently prescribed by oral route for the management of acute pain associated with musculoskeletal conditions. For the ease of application, enhanced stability,
decreased side effects, enhanced patient compliance, and the ease of
discontinuation on desire, there have been a lot of efforts to deliver AC by
topical route. This comparative clinical study to evaluate the efficacy and safety of Aceclofenac combination topical ointment, 1.5% w/w with
HIFENAC GEL® ,1.5% w/w, for the Management of Acute Pain in
Musculoskeletal Conditions. Total 186 subjects will be
randomized in this study 93 subjects in each
treatment arm. All subjects will have
to apply study treatment topically to the affected area 2 times daily
for 8 days. Efficacy of the study drug will be measured by in terms of pain intensity, overall clinical response and need for the rescue medications and safety by reported adverse events during the study. |