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Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
This study has been completed.
Sponsor:
Anthera Pharmaceuticals
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00095732
First received: November 9, 2004
Last updated: October 15, 2014
Last verified: October 2014
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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
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 ]
Secondary Outcome Measures:
- 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 ]
| 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:
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:
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:
Drug: Placebo
Administered orally in either Size 2 or Size 5 capsules
|
Eligibility| Ages Eligible for Study: | 7 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00095732
Show 27 Study Locations
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 ( Other Identifier: Eli Lilly and Company ) TC-2A ( Other Identifier: Altus/Alnara ) |
| Study First Received: | November 9, 2004 |
| Last Updated: | October 15, 2014 |
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 August 18, 2017