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Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months

NCT02442752 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-04-15

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) \[after daily administration for 7 days\] and safety \[after daily administration for 8 weeks\] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.

Conditions

  • Pediatric Gastroesophageal Reflux Disease

Interventions

DRUG

Dexlansoprazole

Dexlansoprazole capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
11 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2025-12-23
Completion
2025-12-23
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Italy
  • Mexico
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442752 on ClinicalTrials.gov