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NCT02138136 · ClinicalTrials.gov registry record · Phase 3
Lubiprostone for Children With Constipation
A Phase 3 study of Constipation - Functional, sponsored by Sucampo Pharma Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 419
- Enrollment target
- 20
- Study locations
NCT02138136: Completed Phase 3 study of Constipation - Functional, sponsored by Sucampo Pharma Americas.
NCT02138136 is a Phase 3 study of Constipation - Functional that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 419 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02138136, a Phase 3 study of Constipation - Functional, has completed, sponsored by Sucampo Pharma Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 419 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): * were invited to participate * will receive lubiprostone for 9 more months * will see if lubiprostone safely relieves their constipation if taken for a whole year
Primary Outcome
Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
Conditions Studied
Interventions
- DRUG Lubiprostone
Study Locations (20)
Florida
- University of Florida - Gainesville
- Palmetto Professional Research - Hialeah
- Nemours Children's Clinic - Jacksonville
- Acevedo Clinical Research Associates - Miami
- Savin Medical Group Research Center - Miami Lakes
- Nemours Childrens Clinic - Pensacola
California
- WCCT Global - Costa Mesa
- Loma Linda University Health Care - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- University of California, San Francisco - San Francisco
Arizona
- Arizona Children's Center at Maricopa Medical Center - Phoenix
- Phoenix Children's Hospital - Phoenix
Arkansas
- Northwest Arkansas Pediatric Clinic - Fayetteville
- Arkansas Childrens Hospital Research Institute - Little Rock
Alabama
- University of South Alabama Women's and Children's Hospital - Mobile
Colorado
- MCB Clinical Research - Colorado Springs
Delaware
- Nemours/Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Emmerson Clinical Research - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 419 participants |
| Start Date | 2014-02-26 |
| Est. Completion | 2017-05-01 |
| Phase | Phase 3 |
What the finished NCT02138136 record still lists
NCT02138136 is an interventional study that assigns participants to a tested intervention. The registered 419 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Constipation - Functional appearing as the primary indexed condition, and to 1 intervention - of which Lubiprostone is the first listed.
NCT02138136 names 20 study sites across 10 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02138136 about?
NCT02138136 is a clinical study titled "Lubiprostone for Children With Constipation". This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): * were invited to participate * will receive lubiprostone for 9 more months * will see if lubiprostone safely relieves their constipation if taken for a whole year
What is the current status of trial NCT02138136?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 419 participants. The study started on 2014-02-26. Estimated completion is 2017-05-01.
What conditions does trial NCT02138136 study?
This clinical trial studies the following conditions: Constipation - Functional.
What interventions are being tested in trial NCT02138136?
The interventions under investigation include: Lubiprostone (DRUG).
Who is sponsoring clinical trial NCT02138136?
This trial is sponsored by Sucampo Pharma Americas, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02138136 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02138136's enrollment target sits among peer trials
419 899th of 2000 higher than 1,101 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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