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Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

17. januar 2013 opdateret af: Takeda

A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Uterine Fibroids

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

216

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Japan
    • Chiba
      • Chiba-shi, Chiba, Japan
      • Itchihara-shi, Chiba, Japan
      • Matsuno-shi, Chiba, Japan
    • Ehime
      • Matsuyama-shi, Ehime, Japan
      • Nihama-shi, Ehime, Japan
    • Fukui
      • Fukui-shi, Fukui, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Iizuka-shi, Fukuoka, Japan
      • Yanagigawa-shi, Fukuoka, Japan
    • Gunma
      • Mebashi-shi, Gunma, Japan
    • Hokkaido
      • Ebetsu-shi, Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Japan
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan
      • Kobe-shi, Hyogo, Japan
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan
      • Yokohama-shi, Kanagawa, Japan
    • Oita
      • Oita-shi, Oita, Japan
    • Osaka
      • Ibaraki-shi, Osaka, Japan
      • Osaka-shi, Osaka, Japan
      • Sakai-shi, Osaka, Japan
      • Tondabayashi-shi, Osaka, Japan
    • Tokyo
      • Chuo-ku, Tokyo, Japan
      • Itabashi-ku, Tokyo, Japan
      • Setagaya-ku, Tokyo, Japan
      • Shinagawa-ku, Tokyo, Japan
      • Suginami-ku, Tokyo, Japan
    • Toyama
      • Toyama-shi, Toyama, Japan

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
  2. The participant is a premenopausal woman.
  3. The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
  4. The participant has experienced regular menstrual cycles
  5. The participant is diagnosed as menorrhagia

Exclusion Criteria:

  1. Participants with a screening Hb <8 g/dL
  2. Participants with a previous or current history of blood disorders
  3. Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
  4. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
  5. Participants with a previous or current history of thyroid dysfunction
  6. Participants with a previous or current history of pelvic inflammatory disease
  7. Participants with a positive PAP smear test result
  8. Participants with a history of panhysterectomy or bilateral oophorectomy
  9. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
  10. Participants with a previous or current history of a malignant tumor
  11. Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide, or denosumab
  12. Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
  13. Participants who have been treated with a bisphosphonate preparation
  14. Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs
  15. Participants with non-diagnosable abnormal genital bleeding
  16. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
  17. Participants with clinically significant cardiovascular disease or uncontrollable hypertension
  18. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
  19. Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN)

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
Medicin: Placebo
TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.
Eksperimentel: TAK-385 10 mg QD
Medicin: TAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
Medicin: TAK-385
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
Medicin: TAK-385
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
Eksperimentel: TAK-385 20 mg QD
Medicin: TAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
Medicin: TAK-385
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
Medicin: TAK-385
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
Eksperimentel: TAK-385 40 mg QD
Medicin: TAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
Medicin: TAK-385
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
Medicin: TAK-385
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decrease in menstrual blood loss
Tidsramme: Week 12 (one menstrual cycle)
Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).
Week 12 (one menstrual cycle)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knoglemineraltæthed
Tidsramme: Op til uge 12.
Målt ved Dual-energy X-ray absorptiometri (DXA)
Op til uge 12.
Kropsvægt
Tidsramme: Op til uge 12.
Op til uge 12.
Decrease in menstrual blood loss
Tidsramme: Up to Week 6
Blood loss will be assessed using PBAC
Up to Week 6
Decrease in menstrual blood loss
Tidsramme: Up to Week 12.
Blood loss will be assessed using PBAC
Up to Week 12.
Amenorrhea
Tidsramme: Week 12 (one menstrual cycle).
Amenorrhea will be assessed using PBAC
Week 12 (one menstrual cycle).
Amenorrhea
Tidsramme: Up to Week 6.
Amenorrhea will be assessed using PBAC
Up to Week 6.
Amenorrhea
Tidsramme: Up to Week 12.
Amenorrhea will be assessed using PBAC
Up to Week 12.
Change in menstrual blood loss
Tidsramme: Week 12 (one menstrual cycle)
Change in menstrual blood loss measured by PBAC
Week 12 (one menstrual cycle)
Myoma Volume
Tidsramme: Up to Week 12.
Up to Week 12.
Uterine Volume
Tidsramme: Up to Week 12.
Up to Week 12.
Hemoglobin Concentration in Blood
Tidsramme: Up to Week 12.
Up to Week 12.
Pain Symptom
Tidsramme: Up to Week 12.
Measured by Numerical Rating Scale.
Up to Week 12.
Other Clinical Symptoms
Tidsramme: Up to Week 12.
Assessed by clinical laboratory tests
Up to Week 12.
Quality of Life (QOL) Score
Tidsramme: Up to Week 12.
QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL)
Up to Week 12.
Treatment-emergent Adverse Events
Tidsramme: Up to Week 16.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
Up to Week 16.
Vital Signs
Tidsramme: Up to Week 12.
Vital signs will include body temperature, sitting blood pressure, and pulse (bpm).
Up to Week 12.
Electrocardiograms
Up to Week 12.
Laboratory Values
Tidsramme: Up to Week 12
Up to Week 12
Serum NTx
Tidsramme: Up to Week 12
NTx is one of the biochemical bone metabolism markers
Up to Week 12
Serum BAP
Tidsramme: Up to Week 12
BAP is one of the biochemical bone metabolism markers
Up to Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Takeda

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. oktober 2011

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

31. august 2011

Først indsendt, der opfyldte QC-kriterier

12. oktober 2011

Først opslået (Skøn)

17. oktober 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TAK-385/CCT-001
  • U1111-1123-6815 (Registry Identifier: WHO)
  • JapicCTI-111590 (Registry Identifier: JapicCTI)

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 Uterine fibromer

Kliniske forsøg med TAK-385

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ireland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner