Multi-Center, 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 - ND
- Conditions
- Pediatric Subjects with Endoscopically Proven GERDMedDRA version: 9.1Level: LLTClassification code 10017791Term: Gastric irritation
- Registration Number
- EUCTR2008-004837-54-IT
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 127
Boy or girl, 1 to 11 years of age; Have a history of at least 1 GERD symptom within the 3 months before the screening phase. Symptoms 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) as well as other clinical signs and symptoms considered to be GERD-related in the opinion of the investigator; Positive EGD (Hetzel and Dent classification, grade >1 and Histological Features of Reflux Esophagitis scale, grade >0) (See Attachment 3 for a description of the grading guidelines and procedure). pHmetry can be performed in addition to the endoscopy if clinically indicated. Assessments have to be done during the 14-day screening period; The parents (preferably both parents, if available) or the legally acceptable representatives 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; Female subjects who have reached their menarche 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 anti-epileptic drug 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 β-human chorionic gonadotropin (β-hCG) pregnancy test at screening. To participate in the optional pharmacogenomic component of this study, parents (or their 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). Assent must be obtained from subjects according to local regulations. Refusal to consent for this component does not exclude a subject from participation in the clinical study; 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
I principali criteri di esclusione comprendono: una storia di esofagite eosinofila, di allergia persistente alle proteine del latte, o di gastroenteropatia allergica, i soggetti che hanno assunto PPI o H2-bloccanti entro i 3 giorni precedenti l`assegnazione casuale, soggetti che hanno assunto sucralfato o un qualsiasi farmaco in grado di influenzare la motilita` gastrointestinale, come ad esempio caffeina, baclofene, eritromicina, metoclopramide, digossina o preparazioni derivanti da Digitalis, chetoconazolo, teofillina, e/o domperidone, entro 3 giorni dall`inclusione nello studio; soggetti infettati da H. pylori (secondo quanto documentato dallo sperimentatore usando metodiche invasive e non invasive convalidate per la diagnosi ed evidenza di ulcerazione attiva o di emorragia gastrointestinale recente; soggetti che presentano valori di laboratorio che assumano rilievo clinico al di fuori del normale intervallo appropriato per l`eta`, con conferma tramite misurazione ripetuta entro 7 giorni (se i risultati dell`analisi non rientrano nell`intervallo di riferimento del laboratorio per l`eta` del soggetto, quest`ultimo potra` essere incluso unicamente qualora lo sperimentatore decida che i valori anomali non rivestono rilevanza clinica. Invece di una ripetizione del prelievo di laboratorio, sono consentiti risultati di laboratorio ottenuti entro 48 ore dallo screening); soggetti che hanno partecipato a una ricerca vertente su un farmaco sperimentale qualsiasi entro i 30 giorni precedenti il periodo dello screening, per tutta la durata del presente studio e 3 giorni dopo aver completato quest`ultimo; soggetti che manifestano allergie nei confronti dei PPI o di qualsiasi principio inattivo contenuto nella formulazione sperimentale; una qualunque condizione che, a giudizio dello sperimentatore, comprometterebbe il benessere del soggetto o il buon andamento dello studio; il genitore o il rappresentante legalmente accettabile del soggetto e` un dipendente dello sperimentatore o del centro implicato nello studio, con coinvolgimento diretto nella ricerca proposta o in altre eseguite sotto la direzione di tale sperimentatore o centro dello studio, come anche i membri dei nuclei familiari dei dipendenti o dello sperimentatore.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method