Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product

NCT02804282 | Completed Phase 3

• 1 other identifier: CP-00001
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Absence of Major Product Failure

  Freedom from failures leading to infusion errors.

  1-5 hours

Secondary Outcomes (3)

• Local Pain Tolerance

  1-5 hours

• Local Skin Tolerance

  1-8 days

• Incidence of treatment-emergent Adverse Events and Serious Adverse Events

  1-8 days

Study Arms (1)

sc2Wear Furosemide Combination Product

EXPERIMENTAL

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.

Combination Product: sc2Wear Furosemide

Interventions

sc2Wear Furosemide COMBINATION_PRODUCT

Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump)

sc2Wear Furosemide Combination Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Male and female Subjects ≥18 years of age
• New York Heart Association (NYHA) Class II-IV Heart Failure.
• In the opinion of the Investigator, able to participate in the study.
• 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).
• 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.
• Has the ability to understand the requirements of the study, and is willing to comply with all study procedures.

You may not qualify if:

• Contraindication to furosemide.
• History of chronic skin conditions requiring medical therapy.
• Skin reaction to medical adhesives or history of poor skin adherence of adhesives.
• Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.
• Diabetic patients currently using an insulin pump and/or interstitial glucose monitors.
• Clinically significant abnormalities at Screening in safety laboratory tests.
• Hypokalemia - Potassium of \< 3.6 mmol/L.
• Systolic BP (SBP) \< 90 mm Hg.
• Temperature \> 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.
• History of major abdominal surgery affecting the site of device placement.
• Participation in another trial, within 30 days prior to Screening.
• History of hepatitis B, hepatitis C, or HIV
• Evidence of current or recent alcohol abuse.
• Female Subject who is pregnant or lactating.
• 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.

Sponsors & Collaborators

• scPharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 17, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 27, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share