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NCT00408317 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 36
- Enrollment target
NCT00408317: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00408317 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 36 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00408317, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis Pharma (formerly Axcan).
Primary Outcome
Percent (%) CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Mean CFA percent was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.
Interventions
- DRUG Placebo
- DRUG Ultrase® MT20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-11 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
What the finished NCT00408317 record still lists
NCT00408317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00408317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00408317 about?
NCT00408317 is a clinical study titled "Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)". The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis Pharma (formerly Axcan).
What is the current status of trial NCT00408317?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 36 participants. The study started on 2006-11. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00408317?
The interventions under investigation include: Placebo (DRUG), Ultrase® MT20 (DRUG).
Who is sponsoring clinical trial NCT00408317?
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 NCT00408317's enrollment target sits among peer trials
36 1901st of 2000 higher than 98 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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