| CTRI Number |
CTRI/2009/091/000882 [Registered on: 23/11/2009] |
| Last Modified On: |
27/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients. |
Scientific Title of Study
Modification(s)
|
A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Lont-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00787891 |
ClinicalTrials.gov |
| RABGRD3003 dated 5 MARCH 2009 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manik Prabhu |
| Designation |
|
| Affiliation |
|
| Address |
Quintiles Research (India) Pvt Ltd., 4th Floor, Nitesh Times Square,
8, M.G. Road,
Bangalore
KARNATAKA
560001
India |
| Phone |
040 40031470 |
| Fax |
040 40031470 |
| Email |
manik.prabhu@quintiles.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
Quintiles Research (India) Pvt Ltd |
| Address |
8th Floor, DLF Square
M Block, Jacaranda Marg
DLF City Phase II
Gurgaon, Haryana
India - 122002
Gurgaon
HARYANA
122002
India |
| Phone |
91-7838652395 |
| Fax |
|
| Email |
shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suchela Srivatsa |
| Designation |
Director – Clinical Operations |
| Affiliation |
Quintiles Research (India) Pvt. Ltd. |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400059
India |
| Phone |
91-9820712114 |
| Fax |
91-22-56774343 |
| Email |
suchela.srivatsa@quintiles.com |
|
|
Source of Monetary or Material Support
|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C., P.O. Box 300, 920 U.S.Route 202 South,
Raritan New Jersey 08869-0602
|
|
Primary Sponsor
Modification(s)
|
| Name |
Johnson Johnson Pharmaceutical Research Development LLC |
| Address |
PO Box 300,920,U.S.Route 202 South, Raritan New Jersey 088690602 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Private Limited |
B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej – Gandhinagar Road, Ahmedabad 380 051 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Hemant Jain |
Chacha Nehru Children Hospital and MGM Medical College |
Medical College Indore ,-452001
Indore
MADHYA PRADESH |
0731 2528535
0731-2512513
jainapeksha@hotmail.com |
| Dr. Murali Krishna |
Manikya Institute of Gastroenterology |
KGH OP bus stop,203 204 MVV Chambers-530002
Visakhapatnam
ANDHRA PRADESH |
0891 320 3340
0891-2713456
muralikrishna63@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee of M.G.M. Medical College |
Approved |
| Institutional Ethics Committee of Andhra medical College |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Gastroesophageal Reflux Disease (GERD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Rabeprazole |
0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks |
| Intervention |
Rabeprazole |
1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
1.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
History of at least 1 GERD symptom within 3 months of screening
Positive esophagogastroduodenoscopy
Signed informed consent
Female patients (if menstruating) must be practicing birth control
|
|
| ExclusionCriteria |
| Details |
Patients with history of esophagitis
Patients who have milk protein allergy
Patients who have taken Proton Pump Inhibitors or H2-blockers within 3 days
Patients who have taken sucralate or any medication that affects gastrointestinal motility
Patients with H. pylori
Patients with lab values outside the normal age appropriate range
Patients who have participated in another trial within 30 days before screening
Patients with allergies to Proton Pump Inhibitors
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) of a pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance study. |
Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) of a pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate changes from baseline of endoscopic and histological grade, the percentage of patients with improvement in pH>4; changes in weekly average GERD scores and symptoms |
Evaluate changes from baseline of endoscopic and histological grade, the percentage of subjects with improvement in pH>4; changes in weekly average GERD scores & symptoms |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
28/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
27/01/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).
This is a randomized, double-blind study that consists of two parts. In Part 1, the study will consist of 3 phases: a 14-day screening phase, a double-blind treatment phase of 12 weeks comparing two doses of study drug (0.5 mg/kg or 1.0 mg/kg groups based on patient's body weight), and an end-of-study or early withdrawal phase followed by Part 2, which consists a of double-blind treatment continuation for patients who have achieved healing during the short-term double-blind treatment phase. The double-blind maintenance treatment phase lasts for not more than 24 weeks and is concluded by an end-of-study/early withdrawal visit.
Oral rabeprazole 2.5 capsules or 5 mg capsules, given once daily at a dose of 0.5 mg/kg or 1.0 mg/kg; short-term treatment phase is 12 weeks; long-term maintenance treatment phase is 24 weeks. Target sample size for India is 8 and the date of first enrollment in India is January 28, 2010.
|