Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product

June 25, 2018 updated by: scPharmaceuticals, Inc.

Open Label Study to Evaluate Product Design Clinical Performance of a To-Be-Marketed Drug-Device Combination Product (sc2Wear Furosemide Combination Product) in Subjects With Chronic Heart Failure

The proposed single-dose study aims to evaluate the product design clinical performance of the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination Product, in adult Subjects previously diagnosed with mild to advanced heart failure.

The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the sc2Wear Furosemide Pump adhered to the body using medical grade adhesive.

The objectives of this study are:

  • To demonstrate that the to-be-marketed drug-device combination product performs as intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area
  • To assess safety and local tolerance of the drug-device combination product

Study Overview

Status

Completed

Conditions

Detailed Description

This study will be an open label, single-dose study to evaluate product design clinical performance of a to-be-marketed drug-device combination product (sc2WearTM Furosemide Combination Product) in up to 70 adult male and female Subjects previously diagnosed with mild to advanced heart failure (NYHA Class II-IV). The study was designed and powered to achieve "95/95" performance testing. Methodology: Each Subject will complete Screening, Treatment, and Follow-Up Phases on an outpatient basis. During the Screening Phase, all Subjects who sign the informed consent form and satisfy the inclusion/exclusion criteria will be enrolled into the trial. Drug administration may start on the day of enrollment or be scheduled within 3 days of completion of Screening assessments. However, if the treatment visit doesn't occur within 3 days of initial screening, subjects may be rescreened and treated within 3 days of rescreening. The Treatment Phase comprises a preprogrammed bi-phasic 5 hour drug administration. Treatment Day observations will commence with pre-placement assessments and continue until after device removal. Device preparation, placement and removal will be performed by study staff in accordance with product instructions of use. Removal will occur within 3 hours of completion of drug delivery (8 hours of start of administration). Subjects will return 5-7 days after the Treatment Day for a post treatment follow-up and photography.

Blood samples will be obtained for the measurement of plasma furosemide levels prior to start of the administration and once during the plateau phase (1-5 hours following activation). After preparation of the skin the device will be placed on the upper abdominal area by clinical study staff. Subjects are advised to avoid strenuous physical activity or activities that could expose the device to moisture such as swimming, bathing or showering. Participants will be informed that marked diuresis may ensue after activation, and that they should avoid travel, operating a vehicle or other situations without immediate access to bathroom facilities. For this study, up to 70 unique reusable components (Activator) will be used. Likewise, up to 70 single-use units (Cartridge) will be used. Following removal from the skin, the assembled device will be inspected and photographed by the site staff. The used device (assembled Cartridge and Activator) will be placed in a sealed container and returned for further inspection and measurement of residual volume in the device reservoir by a qualified laboratory.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
  2. Male and female Subjects ≥18 years of age
  3. New York Heart Association (NYHA) Class II-IV Heart Failure.
  4. In the opinion of the Investigator, able to participate in the study.
  5. If Subject is on oral diuretic, willing to suspend the oral furosemide or other loop diuretic treatment on the day of treatment (use of oral diuretic within 8 hours of start of treatment is not permitted).
  6. If Subject has significant body hair on the abdomen, willing to clip or shave the area where the device will be placed prior to treatment.
  7. Has the ability to understand the requirements of the study, and is willing to comply with all study procedures.

Exclusion Criteria:

  1. Contraindication to furosemide.
  2. History of chronic skin conditions requiring medical therapy.
  3. Skin reaction to medical adhesives or history of poor skin adherence of adhesives.
  4. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.
  5. Diabetic patients currently using an insulin pump and/or interstitial glucose monitors.
  6. Clinically significant abnormalities at Screening in safety laboratory tests.
  7. Hypokalemia - Potassium of < 3.6 mmol/L.
  8. Systolic BP (SBP) < 90 mm Hg.
  9. Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.
  10. History of major abdominal surgery affecting the site of device placement.
  11. Participation in another trial, within 30 days prior to Screening.
  12. History of hepatitis B, hepatitis C, or HIV
  13. Evidence of current or recent alcohol abuse.
  14. Female Subject who is pregnant or lactating.
  15. Any surgical or medical condition that -in the opinion of the Investigator - may interfere with participation in the study or that may affect the outcome of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sc2Wear Furosemide Combination Product
Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump) for subcutaneous administration of 80 mg dose delivered over 5 hours.
Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Major Product Failure
Time Frame: 1-5 hours
Freedom from failures leading to infusion errors.
1-5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Pain Tolerance
Time Frame: 1-5 hours
Subject-reported pain using 11 point numeric rating scale of 0 to 10.
1-5 hours
Local Skin Tolerance
Time Frame: 1-8 days
Adhesive site skin inspection for erythema, edema and other local reactions using 8 point scale.
1-8 days
Incidence of treatment-emergent Adverse Events and Serious Adverse Events
Time Frame: 1-8 days
1-8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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