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NCT02734810 Clinical Trial

SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— SIMPLICITY  

Official title:
A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02734810
Other study ID # AN-EPI3332
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2016
Est. completion date March 2017

Study information
Verified date April 2018
Source Anthera Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- For Part A: males or females =7 years of age

- For Part B: males or females 28 days to <7 years

- Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride

- Low fecal elastase

- Fair-to-good nutritional status

Exclusion Criteria:

- History or diagnosis of fibrosing colonopathy

- Distal intestinal obstruction syndrome in 6 months prior to screening

- Receiving enteral tube feedings

- Chronic diarrheal illness unrelated to pancreatic insufficiency

- Liver abnormalities, or liver or lung transplant, or significant bowel resection

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Liprotamase Powder for Oral Solution
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy

Locations
Country Name City State
United States Investigator Site 117 Altamonte Springs Florida
United States Investigator Site 124 Ann Arbor Michigan
United States Investigator Site 110 Atlanta Georgia
United States Investigator Site 114 Aurora Colorado
United States Investigator Site 111 Dallas Texas
United States Investigator Site 118 Durham North Carolina
United States Investigator Site 109 Glenview Illinois
United States Investigator Site 106 Hershey Pennsylvania
United States Investigator Site 138 Hollywood Florida
United States Investigator Site 116 Houston Texas
United States Investigator Site 135 Las Vegas Nevada
United States Investigator Site 139 Little Rock Arkansas
United States Investigator Site 122 Louisville Kentucky
United States Investigator Site 130 Miami Florida
United States Investigator Site 129 Morgantown West Virginia
United States Investigator Site 101 Oklahoma City Oklahoma
United States Investigator Site 136 Oklahoma City Oklahoma
United States Investigator Site Orange California
United States Investigator Site 132 Portland Maine
United States Investigator Site 112 Richmond Virginia
United States Investigator Site 105 Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Anthera Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Number of subjects reporting 1 or more adverse events 1 week
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