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NCT03097861 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
A Phase 3 study, sponsored by Sucampo Pharma Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 552
- Enrollment target
NCT03097861: Completed Phase 3 study, sponsored by Sucampo Pharma Americas.
NCT03097861 is a Phase 3 study that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 552 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03097861, a Phase 3 study, has completed, sponsored by Sucampo Pharma Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 552 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
Primary Outcome
Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.
Interventions
- DRUG Placebo
- DRUG Lubiprostone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 552 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2017-08-17 |
| Phase | Phase 3 |
What the finished NCT03097861 record still lists
NCT03097861 is an interventional study that assigns participants to a tested intervention. The registered 552 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 (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03097861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03097861 about?
NCT03097861 is a clinical study titled "Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo". The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
What is the current status of trial NCT03097861?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 552 participants. The study started on 2017-03-13. Estimated completion is 2017-08-17.
What interventions are being tested in trial NCT03097861?
The interventions under investigation include: Placebo (DRUG), Lubiprostone (DRUG).
Who is sponsoring clinical trial NCT03097861?
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 NCT03097861's enrollment target sits among peer trials
552 678th of 2000 higher than 1,321 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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