Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

19. oktober 2020 opdateret af: Symbiomix Therapeutics

A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

215

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • California
      • San Diego, California, Forenede Stater, 92123
        • Women's Health Care Research Corp.
    • Florida
      • Clearwater, Florida, Forenede Stater, 33759
        • Women's Medical Research Group, LLC
      • North Miami, Florida, Forenede Stater, 33161
        • Healthcare Clinical Data, Inc.
    • Georgia
      • Roswell, Georgia, Forenede Stater, 30075
        • Atlanta North Gynecology, P.C
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University
      • Saginaw, Michigan, Forenede Stater, 48604
        • Saginaw Valley Medical Research Group, LLC
    • New Jersey
      • Lawrenceville, New Jersey, Forenede Stater, 08648
        • Lawrence Ob-Gyn Clinical Research, LLC
      • Plainsboro, New Jersey, Forenede Stater, 08536
        • Scott Eder MD
    • North Carolina
      • New Bern, North Carolina, Forenede Stater, 28562
        • Eastern Carolina Women's Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Clinical Research of Philadelphia, LLC
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38305
        • The Jackson Clinic, PA
    • Texas
      • Houston, Texas, Forenede Stater, 77054
        • TMC Life Research, Inc.
      • San Antonio, Texas, Forenede Stater, 78229
        • Clinical Trials of Texas, Inc.
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23502
        • Tidewater Physicians for Women
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • University of Washington, Harborview Medical Center

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

Kvinde

Beskrivelse

Inclusion Criteria:

  • Are females at least 18 years of age in good general health who are not menopausal.
  • Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
  • Off-white (milky or gray), thin, homogeneous vaginal discharge
  • Vaginal pH ≥ 4.7
  • Presence of clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
  • A positive 10% KOH Whiff test.
  • Have a Gram stain slide Nugent score ≥ 4 at the Baseline visit (Day 1)

Exclusion Criteria:

  • Are pregnant, lactating, or planning to become pregnant during the study.
  • Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex.
  • Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline visit (Day 1).

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Indgives oralt
Medicin: Placebo
Mundtlig
Eksperimentel: SYM-1219 Low Dose
Administered orally
Medicin: SYM-1219
Oral
Andre navne:
  • Secnidazol
Eksperimentel: SYM-1219 High Dose
Administered orally
Medicin: SYM-1219
Oral
Andre navne:
  • Secnidazol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cure of Bacterial Vaginosis
Tidsramme: Study Days 21-30
Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)
Study Days 21-30

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cure of Bacterial Vaginosis
Tidsramme: Study Days 21-30
Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)
Study Days 21-30
Number of Patients With Therapeutic Cure
Tidsramme: Study Days 21-30
Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.
Study Days 21-30
Number of Patients With a Normal Nugent Score
Tidsramme: Study Days 21-30
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Study Days 21-30

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Symbiomix Therapeutics

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.

Generelle publikationer

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. maj 2014

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

16. maj 2014

Først indsendt, der opfyldte QC-kriterier

27. maj 2014

Først opslået (Skøn)

28. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SYM-1219-201

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 .

Kliniske forsøg med Bakteriel vaginose

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner