| CTRI Number |
CTRI/2009/091/000788 [Registered on: 19/11/2009] |
| Last Modified On: |
09/06/2011 |
| Post Graduate Thesis |
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| Type of Trial |
|
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, sustained release hydroxyzine and immediate release hydroxyzine in the treatment of patients with chronic idiopathic urticaria. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of sustained release hydroxyzine vs immediate release hydroxyzine in the treatment of patients with chronic idiopathic urticaria: a randomized, open-label, comparative, multi-centre trial. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| SUN/HYDSR/0109 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Surendra Borgharkar |
| Designation |
|
| Affiliation |
|
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Surendra Borgharkar |
| Designation |
|
| Affiliation |
|
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Surendra Borgharkar |
| Designation |
|
| Affiliation |
|
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
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Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd. |
|
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Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd. |
| Address |
|
| Type of Sponsor |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sukhdeo Patidar |
Baroda Skin Clinic |
318/319, Saraswati Complex,Opp. Manjalpur Atithi Gruh, G. I. D.C. Road Manjalpur-390011
Vadodara
GUJARAT |
02652660845
sukhdeopatidar@gmail.com |
| Dr. Vinay V. Saraf |
Damayanti Polyclinic |
109, Jawahar Nagar,Road No. 1, Goregaon (W)-400062
Mumbai
MAHARASHTRA |
02228773379
drvsaraf@yahoo.com |
| Dr. Kashmira S. Shah |
Dr. Kasmira S. Shah?s Clinic |
B2,B4, Konark Center,Nr. Hotel Anugraha, New Shahupuri-416 001
Kolhapur
MAHARASHTRA |
02312652919
swapshah@rediffmail.com |
| Dr. Vijay P. Zawar |
Dr. Vijay P. Zawar?s Clinic |
21, Shreeram Sankul,Opp. Hotel Panchavati, Vakilwadi-422001
Nashik
MAHARASHTRA |
02532571820
vijayzawar@yahoo.com, |
| Dr. R. R. Chougule |
Laxmi Hospital |
223/E, Nr. Kiran Bunglow,Tarabai Park-416003
Kolhapur
MAHARASHTRA |
02312652616
graceglorykol@yahoo.com |
| Dr. Rajat Bhatiya |
Shraddha Skin Care Clinic |
217-218, 2nd Floor, Dream Land Plaza, Opp. Municipal Market, ,B/h Relax Cinema, New Civil Road-392001
Bharuch
GUJARAT |
02642239301
|
| Dr. Mahesh C. Patel |
Skin Care Clinic |
Opp. Arogyanagar,Nr. Bus Stop-383001
|
02772248480
maheshpatel1975@yahoo.com |
| Dr. Mukesh B. Ruparelia |
Skin Care Hospital |
2nd floor, Dhebar Road,Opp. S.T. Bus Stand, Above Shreeji Medical-360001
Rajkot
GUJARAT |
02812234352
dr_mbruparelia@yahoo.com |
| Dr. Sunil Trivedi |
Trivedi Skin Care and Cosmetic Clinic |
10, Shivdarshan Complex, ,Opp. TVS Auto Point, Parvat Patiya-395010
Surat
GUJARAT |
drsuniltrivedi@gmail.com
drsuniltrivedi@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| COMSARTs Independant Ethics Committee for Dr. Kashmira S. Shah |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Mahesh C. Patel |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Mukesh B. Ruparelia |
Approved |
| COMSARTs Independant Ethics Committee for Dr. R. R. Chougule |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Rajat Bhatiya |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Sukhdeo Patidar |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Sunil Trivedi |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Vijay P. Zawar |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Vinay V. Saraf |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic idiopathic urticaria, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydroxyzine immediate release tablet |
25 mg three times daily for 4 weeks |
| Intervention |
Hydroxyzine Sustained release tablet |
75 mg once daily for 4 weeks |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Male or female patients aged from 18 to 65 years.
2. Patients having minimum 6 weeks history of chronic idiopathic urticaria and were experiencing an active flare.
3. Patient willing to give their informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2. Patients having hypersensitivity to Hydroxyzine.
3. Patients taking pharmacological agents that could interfere with the study drug or interpretation of efficacy.
4. Patients with asthma using leukotriene inhibitors or those requiring chronic inhaled or systemic corticosteroid therapies.
5. Patients with uncontrolled hypertension and/or diabetes.
6. Alcohol abused patients.
7. Patients having porphyria.
8. Patients with renal and hepatic failure.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Average change from baseline in following parameters:
1. Severity of pruritus over last 24 hours.
2. Rating of number of wheals.
3. Rating of average size of the wheals.
4. Rating of duration of pruritus per day.
|
Baseline Visit (day 0), week 2 and week 4 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Assessment of rating of sleep disturbance (difficulty in falling asleep due to itch, awakening due to itch, use of sleep medication).
2. Average change from baseline in Clinical Global Impression on Severity (CGI-S).
3. Evaluation of Clinical Global Impression on Improvement (CGI-I). |
1. Baseline Visit (day 0), week 2 and week 4
2. Baseline Visit (day 0) and week 4
3. week 2 and week 4 |
|
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Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
25/11/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a randomized, open-label, comparative, multi-centre trial comparing the safety and efficacy of sustained release hydroxyzine 75 mg once daily and immediate release hydroxyzine 25 mg three times daily for four weeks in 200 patients with chronic idiopathic urticaria that will be conducted in India only. The primary outcome measures will be evaluation of average change from baseline to end of study in severity of pruritus over last 24 hours, rating of number of wheals, rating of number of size of wheals, rating of number of pruritus per day at baseline visit (day 0), at the end of week 2 and at the end of week 4. The secondary outcomes will be evaluation of rating of sleep disturbance at baseline visit (day 0), at the end of week 2 and at the end of week 4; Clinical global impression on severity (CGI-S) at baseline visit (Day 0) and at the end of week 4; Clinical global impression on improvement (CGI-I) at the end of week 2 and at the end of week 4. The anticipated date of enrollment will be 25th November 2009, subject to registration at CTRI. This is not a global trial. |