An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 25, 2009

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in coefficient of fecal fat absorption from baseline to end of study period. Palatability. Percent carbon dioxide expired by 13C-mixed triglyceride breath test measuring exogenous lipase activity.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00217204 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical Global Impression Severity Subscale. Global Change Subscale. Weight gain/loss. Global Assessment effectiveness. Nitrogen excretion/24 hr. Mean dose of pancrease assessed/day & weight. Mean daily calories, fat intake. Coefficient fat absorption

Original Secondary Outcome Measures ^ICMJE

Clinical Global Impression Severity Subscale. Global Change Subscale. Weight gain/loss. Global Assessment effectiveness. Nitrogen excretion/24 hr.
Mean dose of pancrease assessed/day and weight. Mean daily calories, fat intake. Coefficient fat absorption.

Descriptive Information

Brief Title ^ICMJE

An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption

Official Title ^ICMJE

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

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers

Detailed Description

The objective of this randomized, Investigator-blinded, parallel group, multicenter, pilot study is to evaluate the preliminary safety, palatability and effectiveness of pancrelipase microtablets to improve fat absorption. The hypothesis is that PANCREASE MT will provide effective, safe and palatable pancreatic enzyme supplementation to be used for the treatment of fat malabsorption in a cohort of infants with cystic fibrosis-related pancreatic insufficiency. On Day 1 of the study, parents will be instructed to administer 500 units lipase/kg/meal for a full five days. Stool will be collected and analyzed during the last 72 hours of this baseline period. On Day 6 of the study, subjects will be randomly assigned to one of four treatment groups. Parents will be instructed to administer the appropriate dose for a full five days and stool will be collected and analyzed during the last 72 hours of this randomized treatment period. Patients will receive PANCREASE MT 500 units lipase/kg/meal by mouth for a maximum of five doses per day for the first 120 hours. Patients will receive PANCREASE MT 500, 1000, 1500 or 2000 units lipase/kg/meal by mouth, for a maximum of five meals per day for the next 120 hours.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cystic Fibrosis
Steatorrhea

Intervention ^ICMJE

Drug: Pancrelipase microtablets

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of cystic fibrosis
Excessive discharge of fat in feces
Stable patient requiring pancreatic enzyme therapy

Exclusion Criteria:

No stable antibiotic therapy for small bowel overgrowth
No hypersensitivity to pork products
No use of prokinetics eg, metoclopramide or cisapride within the last 30 days
No nasogastric feeding tube feeding
No use of steroids
No use of concomitant H2 blockers or proton pump inhibitors as concomitant therapy

Gender

Both

Ages

6 Months to 30 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00217204

Responsible Party

Study ID Numbers ^ICMJE

CR002665

Study Sponsor ^ICMJE

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Information Provided By

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Verification Date

September 2009

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