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

Tracking Information
First Received Date ^ICMJE	November 9, 2004
Last Updated Date	June 23, 2005
Start Date ^ICMJE	June 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Coefficient of fat absorption (CFA)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00095732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
Official Title ^ICMJE	A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Cystic Fibrosis Pancreatic Insufficiency
Intervention ^ICMJE	Drug: TheraCLEC™ – Total
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	126
Completion Date	March 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	7 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00095732
Responsible Party
Study ID Numbers ^ICMJE	TC-2A
Study Sponsor ^ICMJE	Altus Pharmaceuticals
Collaborators ^ICMJE	Cystic Fibrosis Foundation
Investigators ^ICMJE
Information Provided By	Altus Pharmaceuticals
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP