A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-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

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10018203Term: GERD; Endoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 year old subjects.

• Registration Number: EUCTR2008-004837-54-BE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-03
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1) Boy or girl, 1 to 11 years of age
2) Have a history of at least 1 GERD symptom within the 3 months before the screening phase; these may include but are not limited to: heart burn or chest pain, dysphagia or feeding refusal, belching or burping, recurrent regurgitation or vomiting, hoarseness, Sandifer syndrome (cough or abnormal neck posturing), wheezing or stridor, failure to thrive, weight loss or poor weight gain, hematemesis, laryngitis, asthma, and otitis or sinusitis (related to GERD) and other (clinical signs and symptoms considered to be GERD-related in the opinion of the investigator);
3) Positive EGD (Hetzel and Dent classification, grade =1 and Histological Features of Reflux Esophagitis scale, grade >0). pHmetry can be performed in addition to the endoscopy if clinically indicated. Assessments have to be done during the 21-day screening period;
4) The parents (preferably both parents, if available but as required by local
regulations) or legally acceptable representative of the potential subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Section 16.2.3, Informed Consent
5) Female subjects who have reached menarche, if sexually active, must be practicing an effective method of birth control (e.g., abstinence, prescription hormonal contraceptives [provided the subject is receiving a dosage that has been adjusted for concomitant use of an AED or other drug known to significantly affect the metabolism of hormonal contraceptives], intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study and have a negative urine ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening;
6) To participate in the optional pharmacogenomic component of this study, parents (preferably both parents, if available, but as required by local
regulations), or legally acceptable representative of the potential subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study;
7) Are able to swallow the age-appropriate formulation.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1) Have a history of or active eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy;
2) Have taken a PPIs or H2 blockers within 3 days before random assignment;
3) Have taken sucralfate or any medication that affects gastrointestinal motility such as caffeine, baclofen, erythromycin, metoclopramide, digoxin or digitalis preparations, ketoconazole, theophylline and/or domperidone within 3 days before random assignment to study drug;
4) Subjects infected with H. pylori (as documented by the investigator using validated invasive or noninvasive methods for diagnosis and evidence of active ulceration or recent gastrointestinal bleeding);
5) Have clinically relevant laboratory values outside the normal age appropriate range confirmed by a repeat measurement within 7 days (If the results of the testing are not within the laboratory’s reference range for the subject’s age, the subject may be included only if the investigator decides the abnormal values are not clinically relevant. Laboratory results performed within 48 hours before screening are permitted, in lieu of a repeat laboratory draw);
6) Have participated in any investigational drug trial within 30 days before the screening period, during the entire period of this study and 3 days after completion of this study;
7) Have allergies to PPIs or any inactive ingredients in the study formulation;
8) Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study;
9) The subject's parents or legally acceptable representative is an employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified