CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 29 enrolled
Drug / intervention
PANCRECARB® (pancrelipase) +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.

Search/NCT00432861
NCT00432861Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Crossover Study to Evaluate the Effectiveness and Safety of PANCRECARB® MS-16 (Pancrelipase) in Reducing Steatorrhea in Children and Adults With Cystic Fibrosis

Digestive Care, Inc.·interventional·Posted Feb 8, 2007·Updated Feb 22, 2012

In Brief

A Phase 3 clinical trial evaluating PANCRECARB® (pancrelipase) and Placebo for Cystic Fibrosis and Pancreatic Insufficiency. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis and pancreatic insufficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Pancreatic Insufficiency
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2007
Enrollment StartJan 1, 2007
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 19.4 years ago

Interventions

PANCRECARB® (pancrelipase)drug

Capsules

Placebodrug

Capsules