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NCT01131507 · ClinicalTrials.gov registry record · Phase 4

PR-018: An Open-Label, Safety Extension of Study PR-011

A Phase 4 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, sponsored by Forest Laboratories.

Completed
Registry status
Phase 4
Development phase
15
Enrollment target
6
Study locations

NCT01131507 is a Phase 4 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency that has completed, run by Forest Laboratories. The registered enrollment target is 15 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT01131507, a Phase 4 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 4
Development phase
15 participants
Enrollment target
6
Study locations

Study Summary

A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

Conditions Studied

Cystic Fibrosis Exocrine Pancreatic Insufficiency

Interventions

  • DRUG EUR-1008 (APT-1008)

Study Locations (6)

Ohio

  • Akron Children's Hospital - Akron
  • Cincinnati Children's Hospital Medical Center - Cincinnati

Florida

  • Nemours Children's Clinic - Jacksonville

Nevada

  • Children's Lung Specialists Ltd. - Las Vegas

Pennsylvania

  • Penn State Milton S. Hershey Medical Center - Hershey

Texas

  • Cystic Fibrosis Care Center - Houston

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2010-07
Est. Completion 2011-12
Phase Phase 4

Sponsor

Forest Laboratories

145 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01131507

The ClinicalTrials.gov registry entry for NCT01131507 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (92% lower). The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which EUR-1008 (APT-1008) is the first listed.

NCT01131507 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Ohio, Florida, Nevada.

Frequently Asked Questions

What is clinical trial NCT01131507 about?

NCT01131507 is a clinical study titled "PR-018: An Open-Label, Safety Extension of Study PR-011". A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

What is the current status of trial NCT01131507?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2010-07. Estimated completion is 2011-12.

What conditions does trial NCT01131507 study?

This clinical trial studies the following conditions: Cystic Fibrosis, Exocrine Pancreatic Insufficiency.

What interventions are being tested in trial NCT01131507?

The interventions under investigation include: EUR-1008 (APT-1008) (DRUG).

Who is sponsoring clinical trial NCT01131507?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01131507 being conducted?

This trial has 6 study locations across Florida, Nevada, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.