Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432861
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2007-02-07
Brief Title:
Evaluation of the Safety and Efficacy of Pancrecarb MS-16 in Cystic Fibrosis
Sponsor:
Digestive Care Inc
Organization:
Digestive Care Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 ie 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
Several strengths of PANCRECARB pancrelipase ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DCI 06-001 | None | None | None |