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SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis (SIMPLICITY)

Primary Purpose

Exocrine Pancreatic Insufficiency, Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Liprotamase Powder for Oral Solution
Sponsored by
Anthera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exocrine Pancreatic Insufficiency focused on measuring Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Liprotamase, Pancreatic Enzyme Replacement Therapy (PERT)

Eligibility Criteria

28 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site 139
  • Investigator Site
  • Investigator Site 114
  • Investigator Site 117
  • Investigator Site 138
  • Investigator Site 130
  • Investigator Site 110
  • Investigator Site 109
  • Investigator Site 105
  • Investigator Site 122
  • Investigator Site 132
  • Investigator Site 124
  • Investigator Site 135
  • Investigator Site 118
  • Investigator Site 101
  • Investigator Site 136
  • Investigator Site 106
  • Investigator Site 111
  • Investigator Site 116
  • Investigator Site 112
  • Investigator Site 129

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A

Part B

Arm Description

Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age

Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years

Outcomes

Primary Outcome Measures

Safety
Number of subjects reporting 1 or more adverse events

Secondary Outcome Measures

Full Information

First Posted
April 6, 2016
Last Updated
April 10, 2018
Sponsor
Anthera Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02734810
Brief Title
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Keywords
Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Liprotamase, Pancreatic Enzyme Replacement Therapy (PERT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A
Arm Type
Experimental
Arm Description
Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age
Arm Title
Part B
Arm Type
Experimental
Arm Description
Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years
Intervention Type
Drug
Intervention Name(s)
Liprotamase Powder for Oral Solution
Other Intervention Name(s)
Liprotamase
Intervention Description
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
Primary Outcome Measure Information:
Title
Safety
Description
Number of subjects reporting 1 or more adverse events
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigator Site 139
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Investigator Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Investigator Site 114
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Investigator Site 117
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Investigator Site 138
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Investigator Site 130
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Investigator Site 110
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Investigator Site 109
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Investigator Site 105
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Investigator Site 122
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Investigator Site 132
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Investigator Site 124
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5212
Country
United States
Facility Name
Investigator Site 135
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89107
Country
United States
Facility Name
Investigator Site 118
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigator Site 101
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Investigator Site 136
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Investigator Site 106
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Investigator Site 111
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
Investigator Site 116
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigator Site 112
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Investigator Site 129
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

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