Pharmacokinetics and Safety Study of Rabeprazole Sodium in 12 to 16 Year Old Subjects

Phase 1

• Conditions: Gastroesophageal Reflux Disease (GERD); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-001878-15-Outside-EU/EEA
• Lead Sponsor: Eisai Medical Research Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-27
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Males and females age 12 to 16 years, with a clinical diagnosis of, or symptoms of, GERD.
2. Subjects had to be able and willing to take the required number of test drug tablets.
3. The ability of the child to swallow an intact tablet had to be confirmed by the site at screening by history taking.
4. Minimum weight of 30 kg.
5. Willingness of the subject and ability to give assent to participate.
6. The subject's parent or guardian provided written informed consent.
7. Post-pubertal females were required to abstain from sexual relations during the course of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
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

1. Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agreed that the nature and severity of any abnormality was unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study.
2. Females who were pregnant, lactating or had a positive urine beta-human chorionic gonadotropin (hCG) laboratory result.
3. Subjects who were unwilling or unable to refrain from smoking or drinking alcohol starting from 48 hours prior to screening and dosing, through the end of the study, and/or a positive urine drug screen.
4. Subjects who were unwilling or unable to abide by the requirements of the study or who violated the prohibitions and restrictions of the study defined in the Study Protocol.
5. Any condition, which in the opinion of the Investigator or Sponsor, would make the subject unsuitable for the study.
6. Participation in another investigational drug study within 30 days prior to drug administration.
7. A subject history of drug allergies or sensitivity to proton pump inhibitors or to their inactive ingredients.
8. A subject history of clinically significant bacterial or viral infection within one month of screening.
9. Subject history of definitive acid-lowering surgery or previous esophageal or gastric surgery, with the exception of a simple closure of a perforated ulcer.

Study & Design

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