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NCT02819297 · ClinicalTrials.gov registry record · Phase 3
BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
A Phase 3 study, sponsored by Braintree Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,020
- Enrollment target
NCT02819297: Completed Phase 3 study, sponsored by Braintree Laboratories.
NCT02819297 is a Phase 3 study that has completed, run by Braintree Laboratories. The registered enrollment target is 1,020 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02819297, a Phase 3 study, has completed, sponsored by Braintree Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,020 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.
Primary Outcome
The primary endpoint is the proportion of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of \> 1 CSBM in that week.
Interventions
- DRUG BLI400 Laxative
- DRUG BLI400 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,020 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-06 |
| Phase | Phase 3 |
What the finished NCT02819297 record still lists
NCT02819297 is an interventional study that assigns participants to a tested intervention. Its 1,020 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 2 interventions - of which BLI400 Laxative is the first listed.
NCT02819297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02819297 about?
NCT02819297 is a clinical study titled "BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults". The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.
What is the current status of trial NCT02819297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,020 participants. The study started on 2016-06. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02819297?
The interventions under investigation include: BLI400 Laxative (DRUG), BLI400 Placebo (DRUG).
Who is sponsoring clinical trial NCT02819297?
This trial is sponsored by Braintree Laboratories, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02819297's enrollment target sits among peer trials
1,020 291st of 2000 higher than 1,708 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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