| CTRI Number |
CTRI/2011/08/001965 [Registered on: 24/08/2011] Trial Registered Retrospectively |
| Last Modified On: |
19/06/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of safety and efficaccy of levocetrizine and olopatadine in patients suffering from hives for more than 6 weeks |
|
Scientific Title of Study
|
A single-blind randomized controlled clinical study comparing the efficacy, tolerability and safety of levocetrizine and olopatadine in chronic urticaria |
| Trial Acronym |
ESLO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita Sil |
| Designation |
MD Post-Graduate Trainee |
| Affiliation |
Burdwan Medical College, Burdwan |
| Address |
S.C Rakshit Rd, Barabazar, PO-Chandannagar
Dist Hooghly
West bengal
Pin 712136
Dept of Pharmacology
Burdwan Medical College
Burdwan-713104
Barddhaman
WEST BENGAL
712136
India |
| Phone |
09477737091 |
| Fax |
|
| Email |
drsilamrita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Santanu Kumar Tripathi |
| Designation |
Professor and Head |
| Affiliation |
Department of Clinical and Experimental Pharmacology |
| Address |
Dept of Clinical and Experimental Pharmacology
School of Tropical Medicine
Chittaranjan Avenue
Kolkata
Dept of Clinical and Experimental Pharmacology
School of Tropical Medicine
Chittaranjan Avenue
Kolkata
Kolkata
WEST BENGAL
700073
India |
| Phone |
09230566771 |
| Fax |
|
| Email |
tripathi.santanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrita Sil |
| Designation |
MD PGT |
| Affiliation |
Burdwan Medical College, Burdwan |
| Address |
S.C Rakshit Rd, Barabazar, PO-Chandannagar
Dist Hooghly
West bengal
Pin 712136
Dept of Pharmacology
Burdwan Medical College
Burdwan-713104
WEST BENGAL
712136
India |
| Phone |
09477737091 |
| Fax |
|
| Email |
drsilamrita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Burdwan Medical College and Hospital
Burdwan
Pin 713104
West Bengal |
|
|
Primary Sponsor
|
| Name |
Burdwan Medical College and Hospital |
| Address |
Burdwan Medical College and Hospital
Burdwan
Pin 713104
West Bengal |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Amrita Sil |
Burdwan Medical College and Hospital |
Burdwan Medical College and Hospital, Burdwan, Pin - 713104
Barddhaman
WEST BENGAL |
09477737091
drsilamrita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Burdwan Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levocetrizine oral tablets |
Levocetrizine (5 mg) oral tablets once daily for 4 weeks |
| Intervention |
Olopatdaine oral tablets |
Olopatadine (5mg) oral tablets twice daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age above 18 years
2. Patients of either sex
3. Patients suffering from urticaria for more than 6 weeks
|
|
| ExclusionCriteria |
| Details |
1 Pregnant or nursing women
2 End stage renal disease
3 Patients having immunosuppression due to drug or disease
4 History of alcohol or substance abuse
5 Subjects working in night-shifts or are likely to change the usual sleep/wake cycle.
6 Patients driving automobiles.
7 Participation in any other clinical trial within past 3 months
8 Patients unwilling to provide written informed consent or unlikely to comply with the trial protocol
9 Any other condition, which in the opinion of the investigators, is not conducive to inclusion of the subject in the trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Urticaria Severity Score(UAS)
Total Symptom Severity Score (TSS),
Patients and Physicians global assessment of disease activity improvement (5 point Likert scale) |
4,9 weeks after randomisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
LFT
Routine haemogram
Serum Urea, Creatinine
Reported adverse effects |
Baseline and 4 weeks after randomisation
Adverse effects recorded at 1, 2, 3, 4, 5, 9 weeks of randomisation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/03/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients of chronic urticaria having symptoms of itching, wheals > 6 weeks were screened according to inclusion/exclusion criteria were randomly allocated oral trial medications (either olopatadine tablets 5 mg or levocetrizine tablets 5 mg) continously for 4 weeks and then on as and when needed basis for another 5 weeks. The effects of the above mentioned antihistamines were recorded with respect to decrease/increase in symtoms. Scoring systems used were Urticaria activity score (UAS), Urticaria total severity score (TSS), Patients’ and Physicians’ global assessment of disease activity improvement (5 point Likert scale). The scores were recorded at 1, 2, 3, 4, 5, 9 weeks after randomisation.
Safety data were collected with respect to baseline and 4th follow-up laboratory values of routine haemogram, LFT, serum urea, creatinine, blood glucose. Also adverse effects were recorded.
Our study hypothesis was that levocetrizine and olopatadine were equally efficacious in the treatment of patients with chronic urticaria. |