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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00217204
Other study ID # CR002665
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated May 17, 2011
Start date July 2005
Est. completion date February 2006

Study information

Verified date April 2010
Source McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 30 Months
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Pancrelipase microtablets


Locations

Country Name City State
n/a

Sponsors (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Secondary 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
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