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

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

This study has been completed.

Study NCT00095732. Last updated on June 23, 2005. Information provided by Altus Pharmaceuticals

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	Coefficient of fat absorption (CFA)
Secondary Outcome Measure ^†	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)
Condition ^†	Cystic Fibrosis Pancreatic Insufficiency
Intervention ^†	Drug: TheraCLEC™ – Total
MEDLINE PMIDs
Links	Related Info

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	126
Start Date ^†	June 2004
Completion Date	March 2005
Eligibility 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
Gender	Both
Ages	7 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00095732
Organization ID	TC-2A
Secondary IDs ^††
Study Sponsor ^†	Altus Pharmaceuticals
Collaborators ^††	Cystic Fibrosis Foundation
Investigators ^†
Information Provided By	Altus Pharmaceuticals
Verification Date	June 2005
First Received Date ^†	November 9, 2004
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.