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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 is a Phase 3 study that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 552 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03097861
The ClinicalTrials.gov registry entry for NCT03097861 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 552 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sucampo Pharma Americas, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03097861 reports 0 study locations.
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.
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