- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01203644
Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair
4. januar 2021 opdateret af: Pacira Pharmaceuticals, Inc
A Phase 2, Multicenter, Randomized, Double Blind, Dose Escalating/ De Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of a Single Dose of Sustained Release Encapsulated Bupivacaine (SKY0402) in the Management of Postoperative Pain in Subjects Undergoing Inguinal Hernia Repair
The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair.
This study evaluated the safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair.
Study drug was administered by surgical wound infiltration at the end of the hernia repair procedure.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
SKY0402 was administered in a dose escalating/de-escalating fashion, with a low starting dose in Cohort 1 that was to be increased or decreased in subsequent cohorts based on safety and analgesic effects.
The decision to proceed to the next cohort (i.e., increase or decrease the dose) was made by a Cohort Data Review Committee following a review of the data from the previous cohort.
Subjects were randomized to receive either SKY0402 or bupivacaine HCl at a ratio of 1:1 in Cohort 1 and at a ratio of 3:1 in subsequent cohorts.
The dose of bupivacaine HCl (100 mg) remained constant for all cohorts.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
76
Fase
- Fase 2
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Males ≥18 years of age at the Screening visit.
- Scheduled to undergo unilateral inguinal hernia repair under general anesthesia, using an open, tension free procedure (e.g., Lichtenstein technique with or without mesh).
- American Society of Anesthesiology (ASA) Physical Class 1 or 2.
- Able and willing to comply with all study visits and procedures.
- Capable of speaking and understanding the local language sufficiently to provide responses to pain assessment scales.
- Willing and capable of providing written informed consent.
Exclusion Criteria:
- Clinically significant electrocardiogram abnormalities at Screening or on Day 1 (pre administration).
- Albumin and/or alpha 1 acid glycoprotein (AAG) below normal levels.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, might have increased the risk of surgery or complicated the subject's postoperative course.
- Opioid medication usage during the 7 day period preceding the administration of study drug.
- Current medical conditions that could have required treatment with analgesic medications in the postoperative period for pain that was not surgically related (e.g., rheumatoid arthritis).
- Body mass index >30 kg/m^2
- Body weight <60 kg.
- History of hypersensitivity or idiosyncratic reaction to amide type local anesthetic agents.
- History of hypersensitivity, idiosyncratic reactions, and other contraindications to the pain control agents (opioid or non-opioid) anticipated to be used postoperatively. These contraindications may have included: angioedema and bronchospastic reactivity to non steroidal anti inflammatory drug, peptic ulcer (active within the last three months), hepatic or renal insufficiency.
- Coagulation disorders or ongoing anticoagulation treatment.
- Administration of an investigational drug within 30 days or five half lives (of elimination), whichever was longer, prior to study drug administration.
- Suspected or known history of substance abuse and/or alcoholism.
- Clinically significant complications during the hernia repair surgery (e.g., excessive bleeding), which might have rendered the subject medically unstable or might have complicated the subject's postoperative course.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Bupivacaine HCl
(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
Single dose of SKY0402 administered locally into the surgical wound.
|
Aktiv komparator: SKY0402
Low dose, low-mid dose, mid-dose, and high dose
|
Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time to First Use of Supplemental Pain Medication
Tidsramme: Through 96 hours postdose
|
The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain
|
Through 96 hours postdose
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Adverse Events
Tidsramme: Through 30 days postdose
|
Safety assessments included monitoring of treatment-emergent adverse events
|
Through 30 days postdose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Kay Warnott, RN, ACNP, Pacira Pharmaceuticals, Inc
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2004
Primær færdiggørelse (Faktiske)
1. januar 2006
Studieafslutning (Faktiske)
1. december 2006
Datoer for studieregistrering
Først indsendt
15. september 2010
Først indsendt, der opfyldte QC-kriterier
15. september 2010
Først opslået (Skøn)
16. september 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SKY0402-C-201
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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