At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 40 enrolled
Drug / intervention
Pancrease MT 10.5, or MT 21 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Apr 21, 2008·Updated May 9, 2014
In Brief
A Phase 3 clinical trial evaluating Pancrease MT 10.5, or MT 21 and Placebo for Pancrease MT 10.5 or MT 21 for Exocrine Pancreatic Insufficiency and 3 related conditions. Completed, enrolled 40 participants across 11 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartAug 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedApr 21, 2008
Enrollment StartAug 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.2 years ago
Interventions
Pancrease MT 10.5, or MT 21drug
Pancrease MT capsules for maximum dose of 10,000 lipase units / Kg / day
Placebo for Pancrease MT 10.5 or MT 21drug
Capsules with Pancrease MT excipients without the active enzymes