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

Anthera Pharmaceuticals129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

129

Conditions

Cystic Fibrosis Pancreatic Insufficiency

Interventions

LiprotamaseDRUG

Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase)

PlaceboDRUG

Administered orally in either Size 2 or Size 5 capsules

Eligibility

Sex: ALLMin age: 7 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pancreatic insufficiency (PI) documented by fecal elastase \<100 mcg/gram measured at screening * 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 * Forced Expiratory Volume Over One Second (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 screening * 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

Locations (27)

Outcomes

Primary Outcomes

Change from baseline up to 19 days in Coefficient of fat absorption (CFA)

Time frame: Baseline, up to 19 days

Secondary Outcomes

Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA)

Time frame: Baseline, up to 19 days

Change from baseline up to 19 days in stool weight

Time frame: Baseline, up to 19 days

Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores

Time frame: Baseline, 29 days

Change from baseline up to 19 days in number of Stools

Time frame: Baseline, up to 19 days

Change from baseline to 28 days in maximum change in glucose response

Time frame: Baseline through 28 days

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

Palo Alto, California, United States

Denver, Colorado, United States

Gainesville, Florida, United States

Jacksonville, Florida, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

Lexington, Kentucky, United States

New Orleans, Louisiana, United States

...and 17 more locations