| CTRI Number |
CTRI/2018/05/013808 [Registered on: 11/05/2018] Trial Registered Prospectively |
| Last Modified On: |
09/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision between Levocetrizine versus combination of Levocetrizine and Desloratidine in the management of urticaria |
|
Scientific Title of Study
|
Comparison of levocetirizine up-dosing versus combination of levocetrizine and desloratidine in chronic urticaria not responding to standard levocetrizine dose: An open-label parallel-arm randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V K Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room no-4070, 4th Floor, Teaching block, Department of Dermatology and Venereology, AIIMS, NewDElhi
Ansari Nagar (East)
Goutam nagar
South
DELHI
110029
India |
| Phone |
011-26593217 |
| Fax |
|
| Email |
vksaiims@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V K Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room no-4070, 4th Floor, Teaching block, Department of Dermatology and Venereology, AIIMS, NewDElhi
Ansari Nagar (East)
Goutam nagar
DELHI
110029
India |
| Phone |
011-26593217 |
| Fax |
|
| Email |
vksaiims@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr V K Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room no-4070, 4th Floor, Teaching block, Department of Dermatology and Venereology, AIIMS, NewDElhi
Ansari Nagar (East)
Goutam nagar
DELHI
110029
India |
| Phone |
011-26593217 |
| Fax |
|
| Email |
vksaiims@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Room no 4070, 4th floor, teaching block, AIIMS, NewDelhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 VK Sharma |
AIIMS, NewDelhi |
Room no-4070, 4th floor, Teaching block, AIIMS, NewDelhi
South
DELHI |
011-26593217
vksaiims@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics comittee,AIIMS,NewDelhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient having chronic spontaneous urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combination of Levocetrizine and Desloratidine |
In the comparator grouppatients will be given levocetirizine 5 mg along with desloratidine 5mg once daily and will be re-evaluated after 2 weeks (visit 4). Those who are not controlled will be given twice the previous doses i.e. levocetirizine 10mg with desloratidine 10mg and the final evaluation will be done after 2 weeks |
| Intervention |
Levocetrizine |
patients will be treated with double the dose of levocetrizine i.e. 10mg/day and will be re-evaluated after 2 weeks by UCT (visit 4). Those who are not well-controlled, levocetirizine will be up-dosed to twice the previous dose i.e. 20 mg/day. Then final evaluation will be done after 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients >18 years of age
b) Patients fulfilling the definition of chronic spontaneous urticaria which is urticarial lesions occurring most days of the week (at least 3 times a week) lasting for 6 weeks or more with no identifiable cause on history or examination
|
|
| ExclusionCriteria |
| Details |
1. Patients not fulfilling the diagnosis of chronic spontaneous urticaria
2. Patients <18 years of age
3. Patients unwilling to participate in the study
4. Patients with physical urticaria, contact urticaria, drug-induced urticaria and urticarial vasculitis
5. Pregnant or breast-feeding female patients
6. Use of systemic steroids or other immunomodulators/immunosuppressants in the last 4 weeks; antihistamines in the last 7 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Proportion of patients achieving complete control of urticaria, as measured by urticaria control test (UCT) |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Proportion of patients achieving complete control of urticaria, as measured by urticaria control test (UCT) |
7 weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chronic urticaria is
a common disease affecting 0.5% to 1% of individuals (lifetime prevalence).
Management of the disease still remains unclear despite multiple clinical
trials. Second-generation H1-antihistamines are recommended as first-line
therapy; the choice and doses of antihistamines and associated drugs are not
specified. The EAACI/GA2LEN/EDF/WAO guidelines recommend increasing the dose of
anti-histaminics up to 4-times in patients non-responding to the conventional
doses of anti-histamines. Drug-related adverse effects, such as sedation is a
concern with higher doses of the same antihistamine. Combination of two
different group of second generation antihistamines may be more efficacious for
the same and associated with less risk of sedation. However, there are no studies
comparing the standard guideline with combination of two second generation
antihistamines. So there is need for a clinical trial comparing these two
regimens for effective management of the urticaria not responding to the
standard dose of antihistamine.Given the lack of
controlled studies assessing the efficacy and safety of high-dose non-sedating
antihistamines in CU, patient safety should be a key consideration when
choosing a specific antihistamine. Additional
well-controlled, well-designed clinical trials in CU are required to clarify
which non-sedating antihistamines should be used, in what dose, and for how
long, when CU does not respond to standard therapy. Clinical recommendations
regarding the use of first-generation antihistamines, increased dosages of
second-generation antihistamines, and third- and fourth-line alternatives for
CU are based on incomplete and inconsistent data. |