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NCT04456517 · ClinicalTrials.gov registry record · Phase 2
Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04456517: Clinical Trial Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT04456517 is a Phase 2 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04456517, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Crohn's disease is an inflammatory disorder that can affect any part of the gastrointestinal (GI) tract. Some patients still experience persistent diarrhea or other symptoms such as abdominal pain even when their Crohn's disease is in remission. Diarrhea and/or abdominal pain that is not responsive to standard therapies can significantly affect a patient's quality of life and ability to work. The purpose of this study is to test the safety and effectiveness of the drug ranolazine in reducing Crohn's disease-associated diarrhea and other symptoms. Ranolazine is approved by the US Food \& Drug Administration (FDA) for chronic angina (a heart condition). This study is investigating if ranolazine could be used in the setting of Crohn's disease.
Primary Outcome
Daily number of loose stools will be collected directly from all subjects using MyCap.
Interventions
- DRUG Placebo
- DRUG Ranolazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2022-10-18 |
| Est. Completion | 2024-04-11 |
| Phase | Phase 2 |
Why NCT04456517 stopped before completion
NCT04456517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 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.
NCT04456517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04456517 about?
NCT04456517 is a clinical study titled "Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy". Crohn's disease is an inflammatory disorder that can affect any part of the gastrointestinal (GI) tract. Some patients still experience persistent diarrhea or other symptoms such as abdominal pain even when their Crohn's disease is in remission. Diarrhea and/or abdominal pain that is not responsive ...
What is the current status of trial NCT04456517?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2022-10-18. Estimated completion is 2024-04-11.
What interventions are being tested in trial NCT04456517?
The interventions under investigation include: Placebo (DRUG), Ranolazine (DRUG).
Who is sponsoring clinical trial NCT04456517?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04456517's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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