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Sponsored by: |
Digestive Care, Inc. |
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Information provided by: | Digestive Care, Inc. |
ClinicalTrials.gov Identifier: | NCT00432861 |
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.
Condition | Intervention | Phase |
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Cystic Fibrosis Pancreatic Insufficiency |
Drug: PANCRECARB® (pancrelipase) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 29 |
Study Start Date: | January 2007 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Pancrecarb(R) MS-16 Capsules
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Drug: PANCRECARB® (pancrelipase)
Capsules
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2: Placebo Comparator |
Drug: Placebo
Capsules
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Pancreatic insufficiency (PI) is a common pathologic condition that occurs in approximately 90% of patients with cystic fibrosis (CF). Pancreatic insufficiency is characterized by both pancreatic enzyme and bicarbonate insufficiencies. Consequently, maldigestion occurs and a variety of essential nutrients are lost through the stools, especially fat and fat soluble vitamins. As a result, patients often experience growth failure and malnutrition. Effective correction of maldigestion is critical to the survival and well-being of these patients.
Several strengths of PANCRECARB® (pancrelipase) (i.e., MS4, MS8, MS16) have been available and used by patients with CF for more than a decade. The digestive enzymes in PANCRECARB® (pancrelipase) act locally in the gastrointestinal tract. The active enzymes hydrolyze fats into glycerol and fatty acids, proteins into peptides and amino acids, and starches into dextrins and maltose. PANCRECARB® (pancrelipase) has the potential to promote increased lipase activity with efficient fat digestion. Efficient fat digestion is important in CF because it may lead to improved nutritional and pulmonary status and ultimately to improved quality of life and enhanced survival.
PANCRECARB® MS-8 (pancrelipase) has been compared to enteric-coated pancreatic enzymes without bicarbonate for its efficacy in reducing steatorrhea in patients with CF. Differences in fat excretion, when subjects received PANCRECARB® MS-8 (pancrelipase) versus enteric-coated enzymes without bicarbonate, were compared using linear modeling. Mean fat excretion decreased significantly in subjects who received PANCRECARB® MS-8 (pancrelipase) compared to enteric-coated enzymes without bicarbonate.
This study has been designed in accordance with FDA 2006 guideline on exocrine pancreatic insufficiency drug products. Assuming that the results of this study demonstrate that therapy with PANCRECARB® MS-16 (pancrelipase) results in clinically and statistically significant improvement in fat absorption relative to placebo in subjects with CF and pancreatic insufficiency, the study results will be part of a submission for marketing approval of PANCRECARB® (pancrelipase).
The study consists of two treatment periods with 72-hour stool collections separated by a washout period. Study subjects will be required to consume a diet high in fat content.
Ages Eligible for Study: | 7 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
(azithromycin is allowed)
United States, Ohio | |
Rainbow Babies and Children's Hospital | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Michael W Konstan, MD | University Hospitals of Cleveland |
Responsible Party: | DCI ( William Humphries ) |
Study ID Numbers: | Pancrecarb, DCI 06-001 |
Study First Received: | February 7, 2007 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00432861 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cystic fibrosis pancreatic insufficiency PANCRECARB® MS-16 (pancrelipase) steatorrhea |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis Lung Diseases |
Infant, Newborn, Diseases Pancreatic Diseases Pancrelipase Steatorrhea Exocrine Pancreatic Insufficiency |
Fibrosis Gastrointestinal Agents Pancrelipase Pharmacologic Actions Digestive System Diseases Pathologic Processes Cystic Fibrosis |
Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Therapeutic Uses Pancreatic Diseases Infant, Newborn, Diseases Exocrine Pancreatic Insufficiency |