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NCT00513682 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
NCT00513682: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00513682 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 9 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00513682, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan). This study is performed in children from 7 to 11 years old.
Primary Outcome
Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined by the stools collected during the 72-hour period in either washout phase or treatment phase. Mean percent CFA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.
Interventions
- DRUG Ultrase® MT20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00513682 record still lists
NCT00513682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Ultrase® MT20 is the first listed.
NCT00513682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00513682 about?
NCT00513682 is a clinical study titled "Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)". This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan). This study is performed in children from 7 to 11 years old.
What is the current status of trial NCT00513682?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2007-07. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00513682?
The interventions under investigation include: Ultrase® MT20 (DRUG).
Who is sponsoring clinical trial NCT00513682?
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 NCT00513682's enrollment target sits among peer trials
9 1992nd of 2000 higher than 8 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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