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NCT04486326 · ClinicalTrials.gov registry record · Phase 4
Crofelemer for Functional Diarrhea
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT04486326: Clinical Trial Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
NCT04486326 is a Phase 4 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04486326, a Phase 4 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the clinical response of patients with diarrhea to crofelemer relative to placebo and evaluate the overall safety and tolerability of crofelemer in the treatment of diarrhea.
Primary Outcome
Average stool consistency score on the scale from 1 to 7 (from Bristol stool form scale (BSFS)). This rates the stool consistency by type from 1-7. BSFS 1 indicates hard stool consistent with constipation, whereas BSFS of 7 indicates loose, watery stool consistent with diarrhea. Therefore, in this study, a higher score indicates more diarrhea/worse outcome
Interventions
- DRUG Placebo
- DRUG Crofelemer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-08-20 |
| Est. Completion | 2022-09-23 |
| Phase | Phase 4 |
Why NCT04486326 stopped before completion
NCT04486326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04486326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04486326 about?
NCT04486326 is a clinical study titled "Crofelemer for Functional Diarrhea". The primary objectives of this study are to evaluate the clinical response of patients with diarrhea to crofelemer relative to placebo and evaluate the overall safety and tolerability of crofelemer in the treatment of diarrhea.
What is the current status of trial NCT04486326?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2020-08-20. Estimated completion is 2022-09-23.
What interventions are being tested in trial NCT04486326?
The interventions under investigation include: Placebo (DRUG), Crofelemer (DRUG).
Who is sponsoring clinical trial NCT04486326?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04486326's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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