|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT01131507 |
|
Date of registration:
|
25/05/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
PR-018: An Open-Label, Safety Extension of Study PR-011
|
|
Scientific title:
|
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) |
|
Date of first enrolment:
|
July 2010 |
|
Target sample size:
|
15 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01131507 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Aptalis Medical Information |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Forest Laboratories |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
N/A
Age maximum:
12 Months
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Exocrine Pancreatic Insufficiency
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: EUR-1008 (APT-1008)
|
|
Primary Outcome(s)
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
[Time Frame: Up to Month 12 or early termination]
|
|
Secondary Outcome(s)
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
[Time Frame: Baseline, Month 3, 6, 9 and 12]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|