| CTRI Number |
CTRI/2023/08/056338 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Electronic Medical Records |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the tolerability, utilitization pattern and effects of Minocycline oral formulation |
|
Scientific Title of Study
|
Tolerability, Drug Utilization Pattern and Effectiveness of Minocycline Oral Formulations in India: A Real World Retrospective Study from Electronic Medical Records |
| Trial Acronym |
MENTOR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SP/DERM/MENTOR/RWE-1-2023 Version 1.0 dated 14 Jul 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chintan Khandhedia |
| Designation |
Overall Trial Coordinator - Team Lead - Clinical Research | RWE |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai - 400063 Maharashtra INDIA
Mumbai
MAHARASHTRA
400063
India |
| Phone |
|
| Fax |
|
| Email |
Chintan.Khandhedia@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Gabhane |
| Designation |
Deputy General Manager |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai - 400063 Maharashtra INDIA
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243244324 |
| Fax |
|
| Email |
Mukesh.Gabhane@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Colette Pinto |
| Designation |
Manager - Clinical Research | RWE |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai - 400063 Maharashtra INDIA
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243244324 |
| Fax |
|
| Email |
Colete.Pinto@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd.
Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai - 400063 Maharashtra INDIA |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Industries Ltd. |
| Address |
CTS No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai - 400063 |
| 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 Mukesh Gabhane |
Healthplix Technologies |
1st floor, 2gethr, Tower B, Mantri Commercio, Outer Ring Rd, Near Sakra World Hospital, Bellandur, Bengaluru - 560103
Bangalore
KARNATAKA |
9619101705
Mukesh.Gabhane@sunpharma.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients ≥12 years of age
Patients prescribed with oral minocycline formulations
Patients with a minimum of 1 follow-up visit data from the index date (first prescription) of oral minocycline formulations |
|
| ExclusionCriteria |
| Details |
Patients not on oral minocycline treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with adverse events during the period of treatment with minocycline oral formulations |
Baseline, Follow up visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Drug utilization pattern of minocycline oral formulations.
Proportion of patients with symptom resolution during the treatment period with minocycline oral formulations in acne. |
Baseline, Follow up visit |
|
|
Target Sample Size
|
Total Sample Size="2200"
Sample Size from India="2200"
Final Enrollment numbers achieved (Total)= "2161"
Final Enrollment numbers achieved (India)="2161" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2023 |
| Date of Study Completion (India) |
22/07/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a retrospective, observational, real-world evidence study from Electronic Medical Records to evaluate the tolerability, drug utilization pattern and effectiveness of Minocycline Oral Formulations in India. |