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NCT00880100 · ClinicalTrials.gov registry record · Phase 3
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT00880100: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00880100 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 49 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00880100, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma (formerly Axcan).
Primary Outcome
Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected at baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and during the 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.
Interventions
- DRUG Ultrase® MT12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
What the finished NCT00880100 record still lists
NCT00880100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Ultrase® MT12 is the first listed.
NCT00880100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00880100 about?
NCT00880100 is a clinical study titled "Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)". Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma (formerly Axcan).
What is the current status of trial NCT00880100?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2009-04. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00880100?
The interventions under investigation include: Ultrase® MT12 (DRUG).
Who is sponsoring clinical trial NCT00880100?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00880100's enrollment target sits among peer trials
49 1860th of 2000 higher than 139 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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