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NCT01142128 · ClinicalTrials.gov registry record · Phase 1
Viokase 16, Viokase16 Plus Nexium and Nexium Alone
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01142128: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT01142128 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01142128, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.
Primary Outcome
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Interventions
- DRUG Nexium (esomeprazole magnesium)
- DRUG Placebo to Nexium
- DRUG Viokase 16 (pancrelipase) + Nexium
- DRUG Viokase 16 + placebo to Nexium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
Why NCT01142128 stopped before completion
NCT01142128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Nexium (esomeprazole magnesium) is the first listed.
NCT01142128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01142128 about?
NCT01142128 is a clinical study titled "Viokase 16, Viokase16 Plus Nexium and Nexium Alone". Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. ...
What is the current status of trial NCT01142128?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01142128?
The interventions under investigation include: Nexium (esomeprazole magnesium) (DRUG), Placebo to Nexium (DRUG), Viokase 16 (pancrelipase) + Nexium (DRUG), Viokase 16 + placebo to Nexium (DRUG).
Who is sponsoring clinical trial NCT01142128?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01142128's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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