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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 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 49 participants.

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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).

Interventions

  • DRUG Ultrase® MT12

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2009-04
Est. Completion 2009-11
Phase Phase 3

Sponsor

Forest Laboratories

145 total trials

What the Registry Record Tells You About NCT00880100

The ClinicalTrials.gov registry entry for NCT00880100 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 49 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 1 intervention - of which Ultrase® MT12 is the first listed.

NCT00880100 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.