| CTRI Number |
CTRI/2010/091/000517 [Registered on: 08/06/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| 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, fexofenadine and montelukast in the treatment of persistent allergic rhinitis |
|
Scientific Title of Study
|
An Open-label, Assessor-blind, Randomized, Active-controlled Clinical Trial to Evaluate Safety, Tolerability and Efficacy of Oral Tablets of Fixed-dose Combination of Montelukast Sodium equivalent to Montelukast 10 mg and Fexofenadine Hydrochloride 120 mg manufactured by Theon Pharmaceuticals Ltd with Oral Tablets of Fexofenadine Hydrochloride 120 mg alone manufactured by Sanofi Aventis Pharmaceuticals Inc. in the treatment of persistent allergic rhinitis |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Theon/CT/Monte_Fexo/1209 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nitin Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R.N.Cooper Hospital, Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R.N.Cooper Hospital, Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nitin Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R.N.Cooper Hospital, Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
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Source of Monetary or Material Support
|
| M/S. Theon Pharmaceuticals Ltd. |
|
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Primary Sponsor
|
| Name |
M/S. Theon Pharmaceuticals Ltd. |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajiv R Oza |
Clinic, Bhavnagar, Rajivoza59@hotmail.com |
,-
Bhavnagar
GUJARAT |
Rajivoza59@hotmail.com |
| dr. Kirti C Patel |
K E M Hospital, Mumbai, pkitic@yahoo.in |
,-
Mumbai
MAHARASHTRA |
pkitic@yahoo.in |
| Dr. Raj G Bhagat |
N H L Muni. Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com |
,-
Ahmadabad
GUJARAT |
Rajpurvi@yahoo.com |
| Dr. Nitin Rathod |
R N Cooper Hospital, Mumbai, nitinmr@yahoo.in |
,-400057
Mumbai
MAHARASHTRA |
nitinmr@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
allergic rhinitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fenofendine and Montelukast |
10 and 120 mg, |
| Comparator Agent |
Fexofenadine |
120mg |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
 Subjects in the age group of 18-75 years (age of assent)
 Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from the parent and/ or the legally accepted representative.
 Patients who had at least 6 months previous history of confirmed diagnosis of allergic rhinitis
 A positive skin-prick test response to at least 1 of 8 allergens [house dust, grass pollens, tree pollens, ragweeds, seasonal allergens, cat fur, cockroach and strong odors]
 Clinically symptomatic at Screening and at the Baseline Visits
 Patients with nasal congestion score of at least 2 using a 4-point scale (0 = none, 3 = severe)
 Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations
 Patients who did not receive either of the study medication
 Women with negative pregnancy test on the randomization day
 Women in childbearing age group agreed to use appropriate contraception during the trial.
|
|
| ExclusionCriteria |
| Details |
 Patients known, or thought to be hypersensitivity to study drugs
 Patients having had upper respiratory tract infection during the 6-week period preceding the study
 Patients with septal deviation, nasal polyps, acute or chronic rhinosinusitis
 Patients with any other condition that might affect nasal breathing or nocturnal sleep pattern
 History of nasal reconstructive surgery
 Patients with abnormal liver and kidney function
 History of asthma or asthmatic bronchitis
 Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval
 History of auto-immune disease
 History of chronic lung disease
 Excluded medications were astemizole within 3 months; oral or parenteral corticosteroids within 1 month; cromolyn, nedocromil, or nasal or ophthalmic corticosteroids within 2 weeks; cetirizine, zilenton, zafirlukast, oral or long-acting inhaled 13-adrenergic agonists or inhaled anticholinergic agents within 1 week; terfenadine, loratadine, or fexofenadine within 72 hours; and short-acting antihistamines and decongestants within 24 hours before visit
 Concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines
 Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
 Participation in other clinical trials the last three months and during study participation
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| The primary objective of this trial is to evaluate any difference between oral tablets of the fixed-dose combination of montelukast 10 mg and fexofenadine 120 mg with Allegra oral tablets, which is Fexofenadine hydrochloride 120 mg alone in treatment of persistent allergic rhinitis in terms of efficacy by virtue of symptomatic improvement during the ten-day study duration. |
10 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of this trial is to evaluate any difference between oral tablets of the fixed-dose combination of montelukast 10 mg and fexofenadine 120 mg with Allegra oral tablets, which is Fexofenadine hydrochloride 120 mg alone in treatment of persistent allergic rhinitis in terms of safety by virtue of comparing adverse events in each arm throughout the trial duration and clinical chemistry profiles at the baseline and end-of-study. |
end of study |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/04/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a randomized, open label, parallel group, multi centre trial comparing the safety efficacy of Fexofenadine 120mg and Montelukast 10 mg daily for 2 months in 200 patients with allergic rhinitis that will be conducted in four centres in India |