| CTRI Number |
CTRI/2024/10/074754 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational Study of Hydroxyzine Hydrochloride sustain release in
Chronic Pruritus patients
|
|
Scientific Title of Study
|
A Prospective Non-comparative Real-World Observational effectiveness and tolerability Study of Hydroxyzine Hydrochloride 50mg Sustain Release formulation for the management of Chronic Pruritus |
| Trial Acronym |
Atarax SR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRL-IND-GGI-053-ATAR/2023, Version 1 dated 30 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Katare |
| Designation |
Head Clinical Research |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories 8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA Hyderabad India
Hyderabad
TELANGANA
500034
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar Joshi |
| Designation |
Medical expert |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories 8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA Hyderabad India
Hyderabad
TELANGANA
500034
India |
| Phone |
9027188269 |
| Fax |
|
| Email |
deveshkj@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratik Shah |
| Designation |
Clinical Project Manager |
| Affiliation |
Tech Observer India Private Limited |
| Address |
Tech Observer India Private Limited 1391/34A Nangal Raya Opposite Govt School D-block Janakpuri New Delhi
New Delhi
DELHI
110046
India |
| Phone |
9099936587 |
| Fax |
|
| Email |
pratik.shah@tech-observer.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories 8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA Hyderabad India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kinal Joshi |
Orchid Laser and Skin clinic |
308 3rd floor samved complex jail road bhavnagar
Bhavnagar
GUJARAT |
9099044646
drkinal@gmail.com |
| Dr Suneel Vartak |
Skin Clinic |
Rajan Complex datta mandir chowk nashik pune highway nashik road
Nashik
MAHARASHTRA |
9373901829
suneel.vartak@gmail.com |
| Dr Manjunath Shenoy |
Yenepoya Medical College Hospital |
A constituent college of Yenepoya university road deralakatte
Dakshina Kannada
KARNATAKA |
9845009976
manjunath576117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Submittted/Under Review |
| Kiran Institutional Ethics committee |
Approved |
| Yenepoya Ethics committee 2 |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L298||Other pruritus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydroxyzine Hydrochloride |
50mg
Sustain Release formulation
Once daily orally
1 month treatment period |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with chronic pruritus (pruritus of more then 6 weeks)
Patients who are prescribed with Hydroxyzine and plan for up dosing to Hydroxyzine HCl 50 mg SR tablets or patients who require Hydroxyzine HCl 50 mg SR tablets (higher dose) or
newly prescribed to Hydroxyzine HCl 50 mg SR tablets and Non
responders to topical and SGA (second-generation
antihistamine) therapy
Patients with Numerical rating scale itch score of 7 to 10
(inclusive) |
|
| ExclusionCriteria |
| Details |
Mild and moderate pruritus due to a primary dermatologic or all other causes other than dermatological causes like systemic
psychogenic and neuropathic
Patients on systemic immunomodulatory agents and anti depressant
Those receiving any centrally acting medication or those with known neurological conditions will be excluded from the study
Patients with a known history of cardiovascular disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the NRS itch score in chronic pruritus subjects on Hydroxyzine HCl 50 mg SR tablets from screening visit (baseline) to follow-up visits at week 1 and week 4.
Change in DLQI measured in chronic pruritus subjects on
Hydroxyzine HCl 50 mg SR tablets from screening visit (baseline) to follow-up visits at week 1 and week 4 |
Week 1 week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frequency and severity of adverse events (AEs) and serious
adverse events (SAEs) in terms of symptoms, signs, and
laboratory assessment
|
Week 1 week 2 week 4 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
31/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Hydroxyzine, a first-generation antihistamine, is approved for managing chronic pruritus. However,
achieving clinically significant improvement often necessitates higher doses, which can lead to increased
peak plasma concentrations (Cmax) and subsequent side effects. To address this concern, a sustainedrelease Hydroxyzine Hydrochloride formulation (Atarax SR tablets) was developed to mitigate Cmax
elevation while ensuring sufficient systemic exposure. Despite its extensive use for chronic pruritus
management, there’s a notable dearth of comprehensive data on hydroxyzine hydrochloride’s
effectiveness in improving PROs, especially in the Indian context. Therefore, this study aims to assess the
effectiveness and tolerability of Hydroxyzine HCl 50 mg sustained release formulation as an anti-pruritic, by gathering data from Indian subjects on the medication Hydroxyzine HCl 50 mg SR tablets for the
treatment of chronic pruritus. |