Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
NCT ID: NCT00095732
Last Updated: 2014-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2004-06-30
2005-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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)
Placebo
Administered orally in either Size 2 or Size 5 capsules
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
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)
Placebo
Administered orally in either Size 2 or Size 5 capsules
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
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)
Placebo
Administered orally in either Size 2 or Size 5 capsules
Interventions
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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)
Placebo
Administered orally in either Size 2 or Size 5 capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
7 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Anthera Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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.
Birmingham, Alabama, United States
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.
Palo Alto, California, United States
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.
Denver, Colorado, United States
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.
Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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.
Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Lexington, Kentucky, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Buffalo, New York, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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.
Pittsburgh, Pennsylvania, United States
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.
Houston, Texas, United States
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.
Salt Lake City, Utah, United States
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.
Burlington, Vermont, United States
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
Countries
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Other Identifiers
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I5L-MC-TCAA
Identifier Type: OTHER
Identifier Source: secondary_id
TC-2A
Identifier Type: OTHER
Identifier Source: secondary_id
14269
Identifier Type: -
Identifier Source: org_study_id
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