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: Liprotamase Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:

Change from baseline up to 19 days in Coefficient of fat absorption (CFA) [ Time Frame: Baseline, up to 19 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA) [ Time Frame: Baseline, up to 19 days ] [ Designated as safety issue: No ]
Change from baseline up to 19 days in stool weight [ Time Frame: Baseline, up to 19 days ] [ Designated as safety issue: No ]
Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores [ Time Frame: Baseline, 29 days ] [ Designated as safety issue: No ]
Change from baseline up to 19 days in number of Stools [ Time Frame: Baseline, up to 19 days ] [ Designated as safety issue: No ]
Change from baseline to 28 days in maximum change in glucose response [ Time Frame: Baseline through 28 days ] [ Designated as safety issue: No ]


Enrollment:	129
Study Start Date:	June 2004
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Low Liprotamase Dose 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	Drug: Liprotamase 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) Other Names: ALTU-135 LY3031642 TheraCLEC - Total Drug: Placebo Administered orally in either Size 2 or Size 5 capsules
Experimental: Mid Liprotamase Dose 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	Drug: Liprotamase 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) Other Names: ALTU-135 LY3031642 TheraCLEC - Total Drug: Placebo Administered orally in either Size 2 or Size 5 capsules
Experimental: High Liprotamase Dose 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	Drug: Liprotamase 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) Other Names: ALTU-135 LY3031642 TheraCLEC - Total Drug: Placebo Administered orally in either Size 2 or Size 5 capsules

Eligibility


Ages Eligible for Study:	7 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095732

Show 27 Study Locations

Sponsors and Collaborators

Anthera Pharmaceuticals

Cystic Fibrosis Foundation Therapeutics

More Information


Responsible Party:	Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00095732 History of Changes
Other Study ID Numbers:	14269 I5L-MC-TCAA TC-2A
Study First Received:	November 9, 2004
Last Updated:	October 15, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:


Pancreatic Insufficiency Cystic Fibrosis Enzymes

Additional relevant MeSH terms:


Fibrosis Cystic Fibrosis Exocrine Pancreatic Insufficiency Pathologic Processes Pancreatic Diseases	Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 26, 2016