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A Study to Investigate the Safety and Efficacy of a Novel Furosemide Regimen

NCT02721511 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-03-24

No results posted yet for this study

Summary

This is a, prospective, single center, open-label, pilot study to evaluate the safety and efficacy of the subcutaneous administration of a novel furosemide formulation. The results of this pilot study will be reviewed to determine the safety of the subcutaneous treatment regimen and to evaluate patient selection criteria for possible at home treatment. The intent is to conduct a future follow on study looking at the feasibility of at home treatment of patients referred to a hospital for treatment of fluid overload.

Conditions

  • Acute Decompensated Heart Failure

Interventions

DRUG

Furosemide Injection Solution 8mg/mL

Furosemide Injection Solution, 8 mg/mL, (total dose =80 mg) administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours by means of the B. Braun Perfusor® Space Infusion Pump System.

Sponsors & Collaborators

  • scPharmaceuticals, Inc.

    collaborator INDUSTRY

  • Todd M Koelling, MD

    lead OTHER

Principal Investigators

  • Todd M Koelling, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-03-07
Completion
2017-03-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02721511 on ClinicalTrials.gov