SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Public ClinicalTrials.gov record NCT02734810. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02734810
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 28 Days and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2016 (Actual)
- Primary completion
- Dec 2016 (Actual)
- Completion
- Mar 2017 (Actual)
- Last update posted
- May 11, 2018
2016 – 2017
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator Site 139 | Little Rock | Arkansas | 72202 | — |
| Investigator Site | Orange | California | 92868 | — |
| Investigator Site 114 | Aurora | Colorado | 80045 | — |
| Investigator Site 117 | Altamonte Springs | Florida | 32701 | — |
| Investigator Site 138 | Hollywood | Florida | 33021 | — |
| Investigator Site 130 | Miami | Florida | 33136 | — |
| Investigator Site 110 | Atlanta | Georgia | 30342 | — |
| Investigator Site 109 | Glenview | Illinois | 60025 | — |
| Investigator Site 105 | Wichita | Kansas | 67214 | — |
| Investigator Site 122 | Louisville | Kentucky | 40202 | — |
| Investigator Site 132 | Portland | Maine | 04102 | — |
| Investigator Site 124 | Ann Arbor | Michigan | 48109-5212 | — |
| Investigator Site 135 | Las Vegas | Nevada | 89107 | — |
| Investigator Site 118 | Durham | North Carolina | 27710 | — |
| Investigator Site 101 | Oklahoma City | Oklahoma | 73104 | — |
| Investigator Site 136 | Oklahoma City | Oklahoma | 73112 | — |
| Investigator Site 106 | Hershey | Pennsylvania | 17033 | — |
| Investigator Site 111 | Dallas | Texas | 75390-9063 | — |
| Investigator Site 116 | Houston | Texas | 77030 | — |
| Investigator Site 112 | Richmond | Virginia | 23298 | — |
| Investigator Site 129 | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02734810, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 11, 2018 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02734810 live on ClinicalTrials.gov.