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Completed Phase 4 Interventional Results available

Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

ClinicalTrials.gov ID: NCT00452335

Public ClinicalTrials.gov record NCT00452335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00452335
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Sucampo Pharma Americas, LLC
Industry
Enrollment
127 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2007 (Type not available)
Primary completion
Oct 2008 (Actual)
Completion
Oct 2008 (Actual)
Last update posted
Dec 17, 2019

2007 – 2008

United States locations

U.S. sites
19
U.S. states
14
U.S. cities
19
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 —
Arkansas Pediatric Clinic Little Rock Arkansas 72005 —
Children's Hospital and Research Center Oakland Oakland California 94609 —
Nemours Children's Clinic - Jacksonville Jacksonville Florida 32207 —
Nemours Children's Clinic - Pensacola Pensacola Florida 32504 —
Center for Children's Digestive Health Park Ridge Illinois 60068 —
University of Illinois at Peoria Peoria Illinois 61613 —
University of Illinois at Chicago Springfield Illinois 62708-0787 —
Indiana University Indianapolis Indiana 46202 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Children's Hospital Boston Boston Massachusetts 02115 —
The Center for Human Nutrition, Inc. Omaha Nebraska 68105 —
AHS Hospital Corporation Morristown New Jersey 07962 —
Children's Research Institute Columbus Ohio 43205 —
Pediatric Associates of Fairfield, Inc. Fairfield Ohio 45014 —
Regional Gastroenterology Associates of Lancaster, Ltd. Lancaster Pennsylvania 17604 —
Southeastern Clinical Research Chattanooga Tennessee 37403 —
Jackson Clinic Jackson Tennessee 38305 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00452335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 17, 2019 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00452335 live on ClinicalTrials.gov.

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