An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption
A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption
Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
A PHASE2 clinical study on Cystic Fibrosis and Steatorrhea, this trial is completed. The trial is conducted by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. and has accumulated 5 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Jul 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.