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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00095732
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : October 17, 2014
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 9, 2004
First Posted Date  ICMJE November 9, 2004
Last Update Posted Date October 17, 2014
Study Start Date  ICMJE June 2004
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
Change from baseline up to 19 days in Coefficient of fat absorption (CFA) [ Time Frame: Baseline, up to 19 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Coefficient of fat absorption (CFA)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Coefficient of nitrogen absorption (CNA)
  • Weight of stools
  • Number of stools
  • Starch digestion and carbohydrate absorption as measured by blood glucose response
  • Quality of life as measured by the Cystic Fibrosis Questionnaire (CFQ)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
Official Title  ICMJE A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Pancreatic Insufficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Liprotamase
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: Liprotamase
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: Liprotamase
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
129
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
126
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00095732
Other Study ID Numbers  ICMJE 14269
I5L-MC-TCAA ( Other Identifier: Eli Lilly and Company )
TC-2A ( Other Identifier: Altus/Alnara )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthera Pharmaceuticals
Study Sponsor  ICMJE Anthera Pharmaceuticals
Collaborators  ICMJE Cystic Fibrosis Foundation
Investigators  ICMJE Not Provided
PRS Account Anthera Pharmaceuticals
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP