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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00452335
The ClinicalTrials.gov registry entry for NCT00452335 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 203-participant average among 54 other Constipation trials with a reported enrollment target (37% lower). The listed sponsor is Sucampo Pharma Americas, which has 14 total studies on file at ClinicalTrials.gov.
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 reports 19 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.