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NCT02042183 · ClinicalTrials.gov registry record · Phase 3
Lubiprostone in Children With Functional Constipation
A Phase 3 study, sponsored by Sucampo Pharma Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 606
- Enrollment target
NCT02042183: Completed Phase 3 study, sponsored by Sucampo Pharma Americas.
NCT02042183 is a Phase 3 study that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 606 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02042183, a Phase 3 study, has completed, sponsored by Sucampo Pharma Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 606 participants
- Enrollment target
Study Summary
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
Primary Outcome
An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.
Interventions
- DRUG Placebo
- DRUG Lubiprostone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2013-12-13 |
| Est. Completion | 2016-07-27 |
| Phase | Phase 3 |
What the finished NCT02042183 record still lists
NCT02042183 is an interventional study that assigns participants to a tested intervention. The registered 606 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 (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02042183 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02042183 about?
NCT02042183 is a clinical study titled "Lubiprostone in Children With Functional Constipation". Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
What is the current status of trial NCT02042183?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 606 participants. The study started on 2013-12-13. Estimated completion is 2016-07-27.
What interventions are being tested in trial NCT02042183?
The interventions under investigation include: Placebo (DRUG), Lubiprostone (DRUG).
Who is sponsoring clinical trial NCT02042183?
This trial is sponsored by Sucampo Pharma Americas, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02042183's enrollment target sits among peer trials
606 606th of 2000 higher than 1,394 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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