| CTRI Number |
CTRI/2011/091/000069 [Registered on: 03/02/2011] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00569192 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Trivedi |
| Designation |
|
| Affiliation |
|
| Address |
401, Nirup Clinical Research India Pvt. Ltd, Hill View Industrial Estate
Amrut Nagar, LBS Marg
Not Applicable
N/A
40008
India |
| Phone |
022-250004573/74 |
| Fax |
022-25004588 |
| Email |
mtrivedi@ncr-india.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohit Trivedi |
| Designation |
|
| Affiliation |
|
| Address |
401, Nirup Clinical Research India Pvt. Ltd, Hill View Industrial Estate
Amrut Nagar, LBS Marg
Not Applicable
N/A
40008
India |
| Phone |
022-250004573/74 |
| Fax |
022-25004588 |
| Email |
mtrivedi@ncr-india.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohit Trivedi |
| Designation |
|
| Affiliation |
|
| Address |
401, Nirup Clinical Research India Pvt. Ltd, Hill View Industrial Estate
Amrut Nagar, LBS Marg
Not Applicable
N/A
40008
India |
| Phone |
022-250004573/74 |
| Fax |
022-25004588 |
| Email |
mtrivedi@ncr-india.com |
|
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Source of Monetary or Material Support
|
| Map Pharmaceuticals, Inc. |
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Primary Sponsor
|
| Name |
MAP Pharmaceuticals, Inc. |
| Address |
|
| 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 = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Pramod Niphadkar |
Asthma Allergy Centre |
Gurukripa, Plot 66, 1st floor,D.V. Road, Hindu Colony Lane-1-400014
|
022-24135718
site176CRC@ncr-india.com |
| Dr. R. Ramesh |
Athmeya Polyclinic & Diagnostic Centre |
No. 2893, 14th Main, 'E' Block,New Mitra School, Rajaji Nagar, 2nd stage-560010
|
080-231-28312
site186CRC@ncr-india.com |
| Dr. Jugesh Chhatwal |
Christian Medical College & Hospital |
,-141008
|
0161-2228780
site189CRC@ncr-india.com |
| Dr. S. Nagarajan |
Coimbatore Chest Clinic |
M.S.S. Memorial Bldg, 8 D.B. Road,R.S. Puram-641002
|
0422-2557415
site182CRC@ncr-india.com |
| Dr. Tushar Sahasrabudhe |
Dr. D.Y. Patil Medical College |
Sant Tukaram Negar,-4110018
|
020-27423676
site180CRC@ncr-india.com |
| Dr. T. Usha Rani |
Gandhi Medical College |
,-500025
|
040-27510051
site185CRC@ncr-india.com |
| Dr. Subba Rao |
John's Medical College & Hospital |
Sarajpur Road,-560034
|
080-22065284
site183CRC@ncr-india.com |
| Dr. Anand Pandit |
King Edward Memorial Hospital |
,-411011
|
020-66037342
site187CRC@ncr-india.com |
| Dr. Mahesh Babu |
Manipal Hospital |
98, Rustombaugh,Airport Road-560017
|
080-25024632
site188CRC@ncr-india.com |
| Dr. Gulshan Sethi |
Maulana Azad Medical College & Associates L.N. |
Bahadur Shah Zafar Marg.,-110002
|
011-23232400 ext. 3330
site177CRC@ncr-india.com |
| Dr. Ashok Kabra |
Monilek Hospital & Research Centre |
Sector-4,-302004
|
0141-2651393
site179CRC@ncr-india.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of KEM Hospital and Research Centre |
Submittted/Under Review |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Asthma in Infants and Children, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MAP0010 |
High Dose; Inhalation; Twice Daily |
| Intervention |
MAP0010 |
low dose; inhalation; twice daily |
| Comparator Agent |
Placebo Comparator |
Inhalation; Twice Daily |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
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| Details |
*Male or female asthmatic children with mild to moderate persistant asthma.
*12 months to 8 years of age.
*For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
*For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted >1 day and affected sleep.
*AND with at least one major or two minor risk factors. |
|
| ExclusionCriteria |
| Details |
*Any other significant childhood illness/abnormality or chronic lung disease.
*Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
*Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
*Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
*Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening. |
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To measure the change from baseline in nighttime and daytime composite symptom scores. |
Time Frame: Prospective |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in clinic FEV1 from baseline. |
Time Frame: Prospective |
| To evaluate lung function (PEF) |
Time Frame: Prospective |
| To evaluate e-diary symptoms (cough, wheeze, breathlessness) |
Time frame: prospective |
|
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Target Sample Size
|
Total Sample Size="360"
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" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/01/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
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
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.
This trial is ongoing in the United States and is listed on Clinicaltrials.gov (ID noted in Secondary ID section above). |