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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 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 36 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00408317
The ClinicalTrials.gov registry entry for NCT00408317 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00408317 reports 0 study locations.
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.
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