MedTrace Logo

Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

NCT00452335 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2019-12-17

Study results available
· View outcomes & findings →

Summary

The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.

Conditions

Interventions

DRUG

Lubiprostone

12 mcg capsule once daily (QD)

DRUG

Lubiprostone

12 mcg capsule twice daily (BID)

DRUG

Lubiprostone

24 mcg capsule twice daily (BID)

Sponsors & Collaborators

  • Sucampo Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Paul Hyman, MD · University of Kansas Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00452335 on ClinicalTrials.gov