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

Phase 2

Completed

• Conditions: Pancreatic Insufficiency; Cystic Fibrosis
• Interventions: Drug: Liprotamase; Drug: Placebo

• Registration Number: NCT00095732
• Lead Sponsor: Anthera Pharmaceuticals

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

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted QC: 2004-11-08
• Study First Submitted: 2004-11-09
• Study First Posted: 2004-11-09
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Liprotamase Dose	Placebo	Liprotamase in a fixed combination of lipase (100,000 units), protease (100,000 units) and amylase (15,000 units) administered orally (one Size 5 capsule of placebo and five Size 2 capsules of liprotamase) with each of three meals and two snacks daily for 28 days
Low Liprotamase Dose	Placebo	Liprotamase in a fixed combination of lipase (5,000 units), protease (5,000 units) and amylase (750 units) administered orally (one Size 5 capsule of liprotamase and five Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days
Mid Liprotamase Dose	Liprotamase	Liprotamase in a fixed combination of lipase (25,000 units), protease (25,000 units) and amylase (3,750 units) administered orally (one Size 5 capsule of liprotamase, one Size 2 capsule of liprotamase, and four Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days
Mid Liprotamase Dose	Placebo	Liprotamase in a fixed combination of lipase (25,000 units), protease (25,000 units) and amylase (3,750 units) administered orally (one Size 5 capsule of liprotamase, one Size 2 capsule of liprotamase, and four Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days
High Liprotamase Dose	Liprotamase	Liprotamase in a fixed combination of lipase (100,000 units), protease (100,000 units) and amylase (15,000 units) administered orally (one Size 5 capsule of placebo and five Size 2 capsules of liprotamase) with each of three meals and two snacks daily for 28 days
Low Liprotamase Dose	Liprotamase	Liprotamase in a fixed combination of lipase (5,000 units), protease (5,000 units) and amylase (750 units) administered orally (one Size 5 capsule of liprotamase and five Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days

Primary Outcome Measures

Name	Time	Method
Change from baseline up to 19 days in Coefficient of fat absorption (CFA)	Baseline, up to 19 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline up to 19 days in stool weight	Baseline, up to 19 days
Change from baseline up to 19 days in number of Stools	Baseline, up to 19 days
Change from baseline to 28 days in maximum change in glucose response	Baseline through 28 days
Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA)	Baseline, up to 19 days
Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores	Baseline, 29 days

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Morgantown, West Virginia, United States