| CTRI Number |
CTRI/2010/091/000135 [Registered on: 25/02/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effect of, Fluticasone Nasal Spray BP (Mfd. By Biodeal Laboratories Pvt. Ltd.) Vs Fluticasone Nasal Spray BP (Mfd. By Glaxosmithkline Pharmaceuticals Ltd) in patients with Allergic Rhinitis |
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Scientific Title of Study
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A randomized double-blind multicentric prospective clinical trial to compare the efficacy, safety and tolerability of Fluticasone Nasal Spray BP (Mfd. By Biodeal Laboratories Pvt. Ltd.) Vs Fluticasone Nasal Spray BP (Mfd. By Glaxosmithkline Pharmaceuticals Ltd) in patients with Allergic Rhinitis |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CT/SC/01/2009 & Version No: V0 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. M.Kumaresan |
| Designation |
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| Affiliation |
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| Address |
Siva ENT Hospital (P) Ltd
No. 159, Llyods Road
Chennai
TAMIL NADU
600014
India |
| Phone |
04428116807 |
| Fax |
91442813390 |
| Email |
kumaresan@doctor.com |
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Details of Contact Person
Scientific Query
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| Name |
Mr. Manoj Vora |
| Designation |
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| Affiliation |
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| Address |
Biodeal Laboratories Pvt. Ltd
508,G.I.D.C Estate
Not Applicable
N/A
363035
India |
| Phone |
42103880 |
| Fax |
42103882 |
| Email |
manojvora@biodealindia.com |
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Details of Contact Person
Public Query
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| Name |
Mr. Manoj Vora |
| Designation |
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| Affiliation |
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| Address |
Biodeal Laboratories Pvt. Ltd
508,G.I.D.C Estate
Not Applicable
N/A
363035
India |
| Phone |
42103880 |
| Fax |
42103882 |
| Email |
manojvora@biodealindia.com |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
Biodeal Laboratories Pvt. Ltd
508, G.I.D.C Estate, Wadhwan City, Dist Surendranagar,Gujarat - 363035 |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Jagannath B |
Ashwini Hospital |
Opp to B.D.K Kalyana Mantapa,B.B Road, Yelahanka-560064
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08042103880
42103882
aashmi12@gmail.com |
| Dr. M.Kumaresan |
Siva ENT Hospital (P) Ltd |
No. 159,Llyods Road-600014
Chennai
TAMIL NADU |
04428116807
91442813390
kumaresan@doctor.com |
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Details of Ethics Committee
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC of Ashwini Hospital |
Approved |
| IEC of Siva ENT Hospital (P) Ltd |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
In this study we will be enrolling cases with Allergic Rhinitis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Fluticasone Nasal Spray BP |
One spray in each nostril twice a day.
morning and evening) |
| Comparator Agent |
Fluticasone Nasal Spray BP |
One spray in each nostril twice a day.
morning and evening) |
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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 |
1. Age 18 - 60 years.
2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
3. Patient with history, signs & symptoms of Allergic Rhinitis. |
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| ExclusionCriteria |
| Details |
1.Patients < 18 & > 60 years
2.History of hypersensitivity to the study drug or similar class of drug.
3.Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
4.Pregnant or lactating women.
5.Patients with serum creatinine greater than 2.5 mg/dl.
6.Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
7.Significant history or presence of glaucoma, cardiovascular or hematological disease.
8.Any clinical significant illness during the 4 weeks prior to day 1 of this study.
9.Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
10.Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
11.Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
12.HIV and Australian Antigen positive subjects.
13.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| Change in signs and symptoms (Clinical efficacy parameters) i.e. Sore Throat, Cough, Sneezing, Headache and Temperature at the end of Treatment. |
At Baseline, Day 7 and Day 14 |
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Secondary Outcome
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| Outcome |
TimePoints |
| Improvement in Global Assessment of efficacy and tolerability of treatment which will be judged by patients and physicians and to assess adverse events. |
At Baseline, Day 7 and Day 14 |
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Target Sample Size
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Total Sample Size="125"
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
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Phase 4 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| 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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The study is A prospective, comparative, randomized, double blind and multi centric trial to Evaluate the Efficacy, Safety and Tolerability of Fluticasone Nasal Spray BP (Mfd. by Biodeal Laboratories Pvt. Ltd.) Vs. Fluticasone Nasal Spray BP (Mfd. by GlaxoSmithkline Pharmaceuticals Ltd) in patients with Allergic Rhinitis for 14 days in 125 patients that will be conducted in two centers in India. The primary outcome measure will be Change in signs and symptoms (Clinical efficacy parameters) i.e. Sore Throat, Cough, Sneezing, Headache and Temperature at the end of Treatment.The secondary outcome measure will be Improvement in Global Assessment of efficacy and tolerability of treatment which will be judged by patients and physicians and to assess adverse events.
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