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COMPLETED Phase 3

SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

NCT02734810 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG Liprotamase Powder for Oral Solution

Study Locations (20)

Florida

  • Investigator Site 117 — Altamonte Springs
  • Investigator Site 138 — Hollywood
  • Investigator Site 130 — Miami

Oklahoma

  • Investigator Site 101 — Oklahoma City
  • Investigator Site 136 — Oklahoma City

Texas

  • Investigator Site 111 — Dallas
  • Investigator Site 116 — Houston

Arkansas

  • Investigator Site 139 — Little Rock

California

  • Investigator Site — Orange

Colorado

  • Investigator Site 114 — Aurora

Georgia

  • Investigator Site 110 — Atlanta

Illinois

  • Investigator Site 109 — Glenview

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2016-06
Est. Completion 2017-03
Phase Phase 3

Sponsor

Anthera Pharmaceuticals

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02734810

The ClinicalTrials.gov registry entry for NCT02734810 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anthera Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention — of which Liprotamase Powder for Oral Solution is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02734810 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, Oklahoma, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02734810 about?

NCT02734810 is a clinical study titled "SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis". 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. T...

What is the current status of trial NCT02734810?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2016-06. Estimated completion is 2017-03.

What conditions does trial NCT02734810 study?

This clinical trial studies the following conditions: Cystic Fibrosis, Exocrine Pancreatic Insufficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02734810?

The interventions under investigation include: Liprotamase Powder for Oral Solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02734810?

This trial is sponsored by Anthera Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02734810 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial