| CTRI Number |
CTRI/2021/07/034559 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
15/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Real world evidence study to assess effectiveness & safety of HAPID® in the management of patients with Knee Osteoarthritis |
|
Scientific Title of Study
|
A prospective, observational, real world evidence study to assess effectiveness & safety of HAPID® (Un-denatured Type II Collagen 40 mg and Aflapin 100 mg) of Wockhardt Limited in the management of patients with Knee Osteoarthritis |
| Trial Acronym |
HAPID PMS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WOC/HAP/PMS-02/21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul Panghate |
| Designation |
Consultant – Orthopedic Surgeon |
| Affiliation |
Criticare Multispeciality Hospital and Research Centre |
| Address |
Plot No 516, Near SBI SME branch, Telli Galli, Andheri – (E), Mumbai 400 069 INDIA
Mumbai
MAHARASHTRA
400069
India |
| Phone |
02230103020 |
| Fax |
|
| Email |
atulpanghate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Dev Mehta |
| Designation |
Head – Medical Affairs |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Limited Wockhardt Towers Bandra Kurla Complex Mumbai - 400051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-26596779 |
| Fax |
|
| Email |
KapilM@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khokan Debnath |
| Designation |
Head of Clinical Operations, Regulatory Affairs & Pharmacovigilance (India & Emerging market) |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Limited Wockhardt Towers Bandra Kurla Complex Mumbai - 400051
Thane
MAHARASHTRA
400051
India |
| Phone |
022-26596765 |
| Fax |
|
| Email |
kdebnath@wockhardt.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Wockhardt Ltd |
| Address |
Wockhardt Limited Wockhardt Towers Bandra Kurla Complex Mumbai - 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Atul Panghate |
Criticare Multispeciality Hospital and Research Centre |
Room No 104, 1st floor, Ortopaedics, Plot No 516, Near SBI SME branch, Telli Galli, Andheri – (E), Mumbai 400 069 INDIA
Mumbai
MAHARASHTRA |
02230103020
atulpanghate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DY Patil Medical College Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HAPID® Capsule |
Aflapin 100 mg and un-denatured type II collagen 40 mg, Once daily, Orally, 90 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Ambulatory adult patient, clinically or radiologically confirmed diagnosis of Knee Osteoarthritis newly prescribed with HAPID® (Un-denatured Type II Collagen and Aflapin), willing to provide written informed consent and comply to the study as per protocol |
|
| ExclusionCriteria |
| Details |
1. History or evidence of hypersensitivity to any component of study medication
2. History of viscosupplementation within 9 months prior to date of screening
3. History of allergy to eggs or chicken
4. Pregnant or lactating women
5. Any other reason which in opinion of investigator preludes participation in study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Mean overall WOMAC score
2. Change in Mean VAS score
3. Change in Mean WOMAC subscales |
Day 1, Day 5, Day 30, Day 60 and Day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Adverse Events, during treatment with HAPID® |
Day 1, Day 5, Day 30, Day 60 and Day 90. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/07/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, observational, real world evidence study to
assess effectiveness and safety of HAPID® (Un-denatured Type II Collagen and Aflapin) of Wockhardt Limited in
the management of patients with Knee Osteoarthritis. |