Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency - Full Text View

Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

This study has been completed.

Sponsors and Collaborators:	Altus Pharmaceuticals Cystic Fibrosis Foundation
Information provided by:	Altus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00095732

Purpose

The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.

Condition	Intervention	Phase
Cystic Fibrosis Pancreatic Insufficiency	Drug: TheraCLEC™ – Total	Phase II

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Official Title:	A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

Further study details as provided by Altus Pharmaceuticals:

Primary Outcome Measures:

Coefficient of fat absorption (CFA)

Secondary Outcome Measures:

Coefficient of nitrogen absorption (CNA)
Weight of stools
Number of stools
Starch digestion and carbohydrate absorption as measured by blood glucose response
Quality of life as measured by the Cystic Fibrosis Questionnaire (CFQ)

Estimated Enrollment:	126
Study Start Date:	June 2004
Estimated Study Completion Date:	March 2005

Eligibility

Ages Eligible for Study:	7 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pancreatic insufficiency (PI) documented by fecal elastase <100 mg/gm measured at the Screening Visit
Diagnosis of CF based upon the following criteria: *two clinical features consistent with CF; and *either genotype with two identifiable mutations consistent with CF, *or sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis.
FEV1 > 30% predicted
Clinically stable with no evidence of acute upper or lower respiratory tract infection

Exclusion Criteria:

Pregnancy, breastfeeding or of childbearing potential and or not willing to use accepted methods of birth control during enrollment in the study
History of fibrosing colonopathy
History of liver transplant or lung transplant
Unable to discontinue enteral tube feedings during the study
Subject weight < 40 kg
Known hypersensitivity to food additives
Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the Screening Visit
Unable to discontinue the use of pancreatic enzymes for a 72-hour period or any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095732

Show 27 Study Locations

Sponsors and Collaborators

Altus Pharmaceuticals

Cystic Fibrosis Foundation

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	TC-2A
First Received:	November 9, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00095732
Health Authority:	United States: Food and Drug Administration

Keywords provided by Altus Pharmaceuticals:

Enzymes

Pancreatic Insufficiency

Cystic Fibrosis

Study placed in the following topic categories:

Digestive System Diseases

Genetic Diseases, Inborn

Respiratory Tract Diseases

Cystic Fibrosis

Fibrosis

Lung Diseases

Infant, Newborn, Diseases

Pancreatic Diseases

Cystic fibrosis

Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on August 29, 2008