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NCT00452335 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
A Phase 4 study of Constipation, sponsored by Sucampo Pharma Americas.
- Completed
- Registry status
- Phase 4
- Development phase
- 127
- Enrollment target
- 19
- Study locations
NCT00452335: Completed Phase 4 study of Constipation, sponsored by Sucampo Pharma Americas.
NCT00452335 is a Phase 4 study of Constipation that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 127 participants, below the 203-participant average among 54 other Constipation trials with a reported enrollment target (37% lower). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00452335, a Phase 4 study of Constipation, has completed, sponsored by Sucampo Pharma Americas.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 127 participants
- Enrollment target
- 19
- Study locations
Study 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.
Primary Outcome
Gathered as part of the daily electronic diary questions.
Conditions Studied
Interventions
- DRUG Lubiprostone
Study Locations (19)
Illinois
- Center for Children's Digestive Health - Park Ridge
- University of Illinois at Peoria - Peoria
- University of Illinois at Chicago - Springfield
Florida
- Nemours Children's Clinic - Jacksonville - Jacksonville
- Nemours Children's Clinic - Pensacola - Pensacola
Ohio
- Children's Research Institute - Columbus
- Pediatric Associates of Fairfield, Inc. - Fairfield
Tennessee
- Southeastern Clinical Research - Chattanooga
- Jackson Clinic - Jackson
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Pediatric Clinic - Little Rock
California
- Children's Hospital and Research Center Oakland - Oakland
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-10 |
| Phase | Phase 4 |
What the finished NCT00452335 record still lists
NCT00452335 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 203-participant average among 54 other Constipation trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Constipation appearing as the primary indexed condition, and to 1 intervention - of which Lubiprostone is the first listed.
NCT00452335 lists 19 locations in 14 states (Illinois, Florida, Ohio).
Frequently Asked Questions
What is clinical trial NCT00452335 about?
NCT00452335 is a clinical study titled "Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation". 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.
What is the current status of trial NCT00452335?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2007-01. Estimated completion is 2008-10.
What conditions does trial NCT00452335 study?
This clinical trial studies the following conditions: Constipation.
What interventions are being tested in trial NCT00452335?
The interventions under investigation include: Lubiprostone (DRUG).
Who is sponsoring clinical trial NCT00452335?
This trial is sponsored by Sucampo Pharma Americas, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00452335 being conducted?
This trial has 19 study locations across Arizona, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00452335's enrollment target sits among peer trials
127 13th of 54 higher than 42 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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