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1 Clinical Trial Details (PDF Generation Date :- Fri, 09 Nov :49:36 GMT) CTRI Number CTRI/2010/091/ [Registered on: 05/10/2010] - Last Modified On 12/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Interventional Drug Randomized, Parallel Group, Active Controlled Trial A clinical trial to study the efficacy and safety of Montelukast and Fexofenadine fixed dose combination tablet Versus Fexofenadine tablet alone in the patients of Allergic Rhinitis. A Phase III, Multicenter, Single blind, Randomized, Comparative, Prospective study to evaluate the Efficacy and Safety of Montelukast and Fexofenadine fixed dose combination tablet Versus Fexofenadine tablet alone in the patients of Allergic Rhinitis. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) LPL/ARCCP/05/10/MF Protocol Number Details of Principal Investigator Dr. S.P. Kulkarni Phone Fax Agarwal Hospital Naupada, Gokhale road, Thane Details Contact Person (Scientific Query) Dr. Alok Chaturvedi Phone Fax Lupin Ltd. Laxmi Tower - C-wing, 4th floor, Bandra Kurla Complex, alokchaturvedi@lupinpharma.com Details Contact Person (Public Query) Dr. Alok Chaturvedi Lupin Ltd. Laxmi Tower - C-wing, 4th floor, Bandra Kurla Complex, page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Phone Fax > Lupin Limited, Type of Sponsor Nil List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Lupin Limited Laxmi Tower, C wing, 4th floor, Bandra Kurla Complex, Pharmaceutical industry-n of Site Site Phone/Fax/ DR. N.J.S. SAGGU M.G.M. Hospital Kamothe,, DR. AZIZ A. MHATE Mhate clinic B-3, Sector 2,Vashi, DR. (Mrs) P. MORALWAR Moralwar day care center DR. VINAY WAGH Padmashri Dr. D. Y. DR. JYOTKAR Padmashri Dr. D. Y. DR. R. S. MANE Padmashri Dr. D. Y. DR. RAMESH KADAM Padmashri Dr. D. Y. Dr. B.C.Patil Padmashri Dr. D.Y.Patil Hospital & Research Institute Sector 1-A,,C.B.D. Belapur Kadamwadi,,.- Kadamwadi,,- Kadamwadi,,.- Kadamwadi,,.- Kadamwadi,, vinay.r.wagh@gmail.co m drsushmajotkar@gmail. com rameshkadam56@rediff mail.com of Approval Status Date of Approval Is? page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Status Approved/Obtained Health Type Patients Date No Date Specified Condition Allergic Rhinitis Type Details Intervention FDC of Montelukast and Fexofenadine chewable tablet Montelukast (10 mg) and Fexofenadine (120 mg) FDC chewable tablet once daily for 14 days Comparator Agent Fexofenadine 120 mg tablet Fexofenadine 120 mg tablet alone once daily for 14 days Age From Age To Gender Details Year(s) 0.00 Day(s) Both Inclusion Criteria 1.Males and females patients more than 18 years of age. 2.Written informed consent signed by patient and willing to comply with the study procedure. 3.Patients with diagnosis of Allergic Rhinitis 4.Except Allergic Rhinitis patients must be in general good health based on screening, vital, systemic examination and medical history. 5.Patients having mild asthma along with Allergic Rhinitis are also allowed to participate provided they used only inhaled, short acting beta-agonists bronchodilators to treat asthma. 6.In case of woman of childbearing potential willing to use effective contraception during the study and willing to undergo pregnancy test. Exclusion Criteria Details Exclusion Criteria 1.Males and females patients less than 18 years of age. 2.Pregnant and lactating women patients. 3.Patients not willing to comply with the study protocol and provide written informed consent to participate. 4.Patients with Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction. 5.Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial. 6.Patients with upper respiratory tract infection or acute or chronic pulmonary disorder. 7.Patients who had initiation of allergen immunotherapy within previous 6 months. 8.Participation in any investigational drug trial within the 90 days preceding the screening visit or planned participation in another investigational drug trial at any time during page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified randomization An Open list of random numbers Participant Blinded this trial. 9.Patients with known hypersensitivity to Montelukast or Fexofenadine or other piperazine derivatives. 10.Patients with known history of rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption will also be excluded from the trial. 11.Patients with history of hepatic impairment (alcohol related liver disease or cirrhosis), renal impairment, cardiac impairment and patients who had recently undergone a major surgical procedure or any other condition that in the judgment of the investigator not suitable to be recruited in the study. 12.The patients who are currently not on for following medications Intranasal or systemic corticosteroids (1 month), Intranasal cromolyn (2 weeks), Intranasal or systemic decongestants (3 days), Intranasal or systemic antihistamines (3 days). 13.Expected use of any other medications for allergic rhinitis or conjunctivitis during the treatment period e.g. antihistamines, corticosteroids (inhaled, oral, parenteral, nasal and ophthalmic), cromolyn sodium, nedocromil and inhaled cholinergics. Oral or long acting beta-agonist, theophylline and leukotriene modifiers are also disallowed. Medications that could affect nasal or ocular symptoms including decongestants and anti-inflammatory drugs are not permitted. No allergic rhinitis rescue medications are permitted during the study. Primary Outcome Outcome Timepoints 1.Daytime nasal symptom score (i.e. the mean of four individual symptoms score: nasal congestion, rhinorrhea, nasal pruritus and sneezing) 2.Nighttime nasal symptom score (i.e. the mean of three symptoms score: difficulty going to sleep, nighttime awakenings, nasal congestion on awakenings) 3.Daily composite symptoms score (i.e. the mean of the daytime nasal symptom score and nighttime nasal symptom score). 4.Individual daytime nasal symptom score 5.Individual nighttime nasal symptom score 6.Peripheral blood Eosinophils 7.Rhinocojunctivitis Quality of Life Questionnaire (RQOL) 8.Physician?s and Patient?s Global assessment of the treatment. 14 Days [Delete] 0, 7th and 14th Days Secondary Outcome Outcome Timepoints 1.To evaluate the safety by assessing the type, number, frequency and proportion of patients with Adverse Event(s) during the trial phase. 2.Concomitant medication (to be taken to overcome any adverse events). 7th and 14th Days Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Total Sample Size=220 Sample Size from =220 01/01/2010 Date of First 01/01/2000 page 4 / 5

5 Powered by TCPDF ( PDF of Trial Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Years=0 Months=0 Days=14 Completed Completed trial not published This will be Phase III, Multicenter, Single blind, Randomized, Comparative, Prospective study involving 200 patients with Allergic Rhinitis receiving Montelukast and Fexofenadine fixed dose combination tablet(investigational Product)Versus Fexofenadine tablet alone (Comparator Product)once daily for 14 days.the treatment period will be for 14 days and patients may be monitored on 7th and 14th day of the trial.patient will undergo systemic examination, vital examination,laboratory investigations i.e. CBC,Pregnancy test (If required)and Rhinocojunctivitis Quality of Life Questionnaire (RQOL)will be assessed.daytime nasal symptom score (each night before bed) and Nighttime nasal symptom score (in the morning on arising) will be assessed everyday from the patient daily diary card. A record of consumption of trial medication, adverse events and use of concomitant medication (to be taken to overcome any adverse events) if any will be also kept in patient diary. Efficacy of investigational and comparator product will be compaired. page 5 / 5