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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01131507
Recruitment Status : Completed
First Posted : May 27, 2010
Results First Posted : March 7, 2014
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE May 25, 2010
First Posted Date  ICMJE May 27, 2010
Results First Submitted Date  ICMJE January 27, 2014
Results First Posted Date  ICMJE March 7, 2014
Last Update Posted Date March 21, 2017
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Month 12 or early termination ]
TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE's relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild [minimal/no treatment and did not interfere with daily activities], moderate [resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning] and severe [interrupted participant's usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating]) with a frequency threshold of above 5% were reported.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
Evaluate AEs during long term treatment [ Time Frame: up to 365 days ]
Evaluate the frequency and severity of treatment-emergent AEs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12 [ Time Frame: Baseline, Month 3, 6, 9 and 12 ]
Participant's ability to thrive was evaluated through growth percentiles for weight-for-age, length-for-age and weight-for-length recorded on Center for Disease Control and Prevention (CDC) growth charts during each treatment visit.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
Subjects ability to thrive [ Time Frame: Up to 365 days ]
Evaluate the long term effects of EUR-1008
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE PR-018: An Open-Label, Safety Extension of Study PR-011
Official Title  ICMJE A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)
Brief 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).
Detailed Description

This is a multi-center, open-label, safety extension of Aptalis (formerly Eurand) study PR-011 (NCT01100606) in pediatric participants with EPI due to CF. The study will be carried out in participants who completed the PR-011 study.

The study is comprised of 5 visits: an enrollment visit, treatment visit 1 (3 months), treatment visit 2 (6 months), treatment visit 3 (9 months) and treatment visit 4 (12 months). Once determined eligible for participation, participants will be enrolled into the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Exocrine Pancreatic Insufficiency
Intervention  ICMJE Drug: EUR-1008 (APT-1008)
EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose will be adjusted based on participants' age and body weight. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment will be up to 12 months.
Other Name: Zenpep® (pancrelipase) 3,000 lipase units delayed release capsules
Study Arms  ICMJE Experimental: EUR-1008 (APT-1008)
Intervention: Drug: EUR-1008 (APT-1008)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2010)
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant's parent or guardian signed informed consent form (ICF)
  • Participants who have completed study PR-011 (NCT01100606)

Exclusion Criteria:

  • Participant having any condition that would, in the investigator's opinion, limit the participant's ability to complete the study or will result in excess risk to the participant that is above the standard of care
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01131507
Other Study ID Numbers  ICMJE PR-018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Forest Laboratories
Original Responsible Party Candace Lee, Manager of Clinical Development and Operations, Eurand Pharmaceuticals, Inc.
Current Study Sponsor  ICMJE Forest Laboratories
Original Study Sponsor  ICMJE Eurand Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aptalis Medical Information Forest Laboratories
PRS Account Forest Laboratories
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP