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

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

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

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Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Florida
University of Florida Health Science Center
Gainesville, Florida, United States, 32610
Nemour's Children's Clinic
Jacksonville, Florida, United States, 32207
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Kentucky Clinic
Lexington, Kentucky, United States, 40536
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, New York
Veteran's Administration of Western New York Healthcare
Buffalo, New York, United States, 14215
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah Health Science Center
Salt Lake City, Utah, United States, 84132
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05401
United States, West Virginia
University of West Virginia
Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

Altus Pharmaceuticals

Cystic Fibrosis Foundation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00095732 History of Changes
Other Study ID Numbers:	TC-2A
Study First Received:	November 9, 2004
Last Updated:	March 24, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Altus Pharmaceuticals:

Enzymes
Pancreatic Insufficiency
Cystic Fibrosis

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases

Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013