Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
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.
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
- Enrollment
- 127 participants
Conditions and interventions
Conditions
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
- Dec 31, 2006
- Primary completion
- Sep 30, 2008
- Completion
- Sep 30, 2008
- Last update posted
- Dec 16, 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 16, 2019 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00452335 live on ClinicalTrials.gov.