- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02804282
Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product
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
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: sc2Wear Furosemid Kombinasjonsprodukt
Medikament-enhetskombinasjonsprodukt av bufret furosemidinjeksjon, (furosemid injeksjonsløsning), 8 mg/ml, og plasterpumpe (sc2Wear Furosemid Pump) for subkutan administrering av 80 mg dose levert over 5 timer.
|
Medikament-enhetskombinasjonsprodukt av bufret furosemid-injeksjon, (furosemid-injeksjonsløsning), 8 mg/ml, og lappepumpe (sc2Wear furosemidpumpe)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fravær av større produktfeil
Tidsramme: 1-5 timer
|
Frihet fra feil som fører til infusjonsfeil.
|
1-5 timer
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Lokal smertetoleranse
Tidsramme: 1-5 timer
|
Pasientrapporterte smerter ved bruk av 11-punkts numerisk vurderingsskala fra 0 til 10.
|
1-5 timer
|
Lokal hudtoleranse
Tidsramme: 1-8 dager
|
Hudinspeksjon på limstedet for erytem, ødem og andre lokale reaksjoner ved hjelp av en 8-punkts skala.
|
1-8 dager
|
Forekomst av behandlingsfremkomne bivirkninger og alvorlige bivirkninger
Tidsramme: 1-8 dager
|
1-8 dager
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CP-00001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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