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

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ClinicalTrials.gov Identifier: NCT00095732
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : October 17, 2014
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Pancreatic Insufficiency Drug: Liprotamase Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
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
Study Start Date : June 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline up to 19 days in Coefficient of fat absorption (CFA) [ Time Frame: Baseline, up to 19 days ]

Secondary Outcome Measures :
  1. Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA) [ Time Frame: Baseline, up to 19 days ]
  2. Change from baseline up to 19 days in stool weight [ Time Frame: Baseline, up to 19 days ]
  3. Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores [ Time Frame: Baseline, 29 days ]
  4. Change from baseline up to 19 days in number of Stools [ Time Frame: Baseline, up to 19 days ]
  5. Change from baseline to 28 days in maximum change in glucose response [ Time Frame: Baseline through 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095732


  Show 27 Study Locations
Sponsors and Collaborators
Anthera Pharmaceuticals
Cystic Fibrosis Foundation Therapeutics
More Information
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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 )
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: October 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