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NCT02323100 · ClinicalTrials.gov registry record · Phase 1
Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)
A Phase 1 study, sponsored by National Jewish Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02323100: Clinical Trial Phase 1 study, sponsored by National Jewish Health.
NCT02323100 is a Phase 1 study that was terminated before completion, run by National Jewish Health. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02323100, a Phase 1 study, was terminated before completion, sponsored by National Jewish Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
We propose to test the effectiveness of the combination of CF pancreatic enzyme replacement therapy (PERT) on absorption of Ravicti® and subsequent restoration of nasal epithelial cystic fibrosis transmembrane conductance regulator (CFTR)-mediated chloride transport during the nasal potential difference (NPD) test. Funding source FDA Office of Orphan Products Development.
Primary Outcome
Change in average measurement of nasal potential difference in millivolts (mV) between baseline (Visit 0) and Day 4 (Visit 2) or Day 7 (Visit 3). Note: the outcome is assessed as change in mV at each visit, and then comparisons between visits are made.
Interventions
- DRUG Placebo
- DRUG Ravicti low dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-12-02 |
| Est. Completion | 2022-03-01 |
| Phase | Phase 1 |
Why NCT02323100 stopped before completion
NCT02323100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02323100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02323100 about?
NCT02323100 is a clinical study titled "Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)". We propose to test the effectiveness of the combination of CF pancreatic enzyme replacement therapy (PERT) on absorption of Ravicti® and subsequent restoration of nasal epithelial cystic fibrosis transmembrane conductance regulator (CFTR)-mediated chloride transport during the nasal potential differ...
What is the current status of trial NCT02323100?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-12-02. Estimated completion is 2022-03-01.
What interventions are being tested in trial NCT02323100?
The interventions under investigation include: Placebo (DRUG), Ravicti low dose (DRUG).
Who is sponsoring clinical trial NCT02323100?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02323100's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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