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Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease
This study is not yet open for participant recruitment.
Verified by Takeda Global Research & Development Center, Inc., February 2009
First Received: February 18, 2009   Last Updated: February 19, 2009   History of Changes
Sponsored by: Takeda Global Research & Development Center, Inc.
Information provided by: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00847210
  Purpose

The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole in adolescent subjects.


Condition Intervention Phase
Gastroesophageal Reflux
Drug: Dexlansoprazole MR
Phase I

MedlinePlus related topics: Esophagus Disorders GERD
Drug Information available for: Dexlansoprazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title: A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Pharmacokinetic Parameters for Dexlansoprazole, including Time to reach the peak concentration. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]) and from time 0 to tau over the dosing interval (AUC[0-tau]). [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Terminal phase elimination half-life (T1/2) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Terminal elimination rate constant (lz) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Oral clearance (CL/F) and apparent volume of distribution (Vz/F) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
2: Experimental Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.

Detailed Description:

Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the reflux of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of Gastroesophageal reflux disease in the pediatric population is becoming increasingly recognized and documented. It is a chronic disease that can persist through adulthood with symptoms in older children and adolescents being similar to those seen in adults. The prevalence of gastroesophageal reflux disease increases with age, from 2.5% of children between the ages of 3 and 9 years, to 8.5% of those between the ages of 10 and 17 years.

Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type gastroesophageal reflux disease symptoms of heartburn and regurgitation. Treatment for gastroesophageal reflux disease is aimed at alleviating symptoms and healing the esophageal inflammation.

This study will evaluate the safety of dexlansoprazole MR in the pediatric population (ages 12-17) and to determine if the pharmacokinetic profile is similar to that in adults given the same dose.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight is greater than or equal to 30 kg.
  • Females of childbearing potential who are sexually active must agree to use an acceptable form of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Must have an estimated creatinine clearance greater than or equal to 80 mL/minute as determined from the Cockcroft-Gault formula.
  • Participants who take prescription or non-prescription proton pump inhibitors, histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a regular or as required basis must agree to discontinue usage throughout the study.
  • Must have a history of gastroesophageal reflux disease symptoms, as documented by a physician, for at least 2 months prior to Screening or is currently symptomatic.
  • Must be able to swallow study drug capsule or must be able to ingest study drug granules sprinkled on 1 tablespoon of applesauce.

Exclusion Criteria:

  • Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic skin rash.
  • Has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of a disease that might interfere with the conduct of the trial or that would contraindicate taking dexlansoprazole MR or a similar drug in the same class.
  • Has a known hypersensitivity to any proton pump inhibitors or any component of the formulation of dexlansoprazole MR (see most current version of the Investigator Brochures).
  • Has a history of malignant disease.
  • Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody.
  • Has a known history of infection with the human immunodeficiency virus.
  • Has donated or lost greater than or equal to 300 mL blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
  • Is required to take or intends to continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
  • Has consumed grapefruit or grapefruit juice within 14 days prior to the first dose of study drug or is unwilling to agree to abstain from grapefruit or grapefruit juice while participating in the study.
  • Has a history of alcohol abuse or illegal drug use or drug abuse in the past, or tests positive for alcohol or drugs of abuse at the initial Screening Visit or Day -1 or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  • Has used a product containing nicotine within 90 days prior to the first dose of study drug or has a positive cotinine screen at the initial Screening Visit or Day -1 or is unwilling to agree to abstain throughout the study.
  • Has participated in a study of an investigational agent (including dosing or follow up) within 30 days prior to first dose of study drug.
  • Has an initial Screening Visit or Day -1 laboratory value that the principal investigator considers to be clinically significant.
  • Subject is determined to be a CYP2C19 isozyme poor metabolizer (ie, genotyped homozygous non-wild type).
  • Is unlikely to comply with the protocol or is unsuitable for any other reason per the opinion of the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847210

Contacts
Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com

Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Director: Medical Director Pharmacovigilance Takeda Global Research & Development Center, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers: T-P107-163
Study First Received: February 18, 2009
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00847210     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
Esophageal Reflux
Gastro-Esophageal Reflux
Gastroesophageal Reflux Disease
GERD
Regurgitation, Gastric
Heartburn
Drug Therapy
Adolescent

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases
Heartburn
Lansoprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Lansoprazole

ClinicalTrials.gov processed this record on May 07, 2009