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MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

1. februar 2022 opdateret af: Organon and Co

A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine

A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

933

Fase

  • Fase 3

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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participant had at least a 6-month history of migraine, with or without aura
  • Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
  • Participant was judged to be in good health, apart from migraine

Exclusion Criteria:

  • Participant was Pregnant or a nursing mother
  • Participant had a history or current evidence of drug or alcohol abuse
  • Participant had a history or clinical evidence of cardiovascular disease
  • Participant had a clinically significant Electrocardiography (ECG) abnormality
  • Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
  • Participant had received treatment with an investigational device or compound within 30 days of the study
  • Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
  • Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
  • Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium

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
Placebo komparator: 3
Placebo
Medicin: Comparator: Placebo
Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
Eksperimentel: 1
Rizatriptan
Medicin: rizatriptan benzoate (MK0462)
single dose 5 mg rizatriptan p.o.
Andre navne:
  • MK0462
Eksperimentel: 2
Sumatriptan
Medicin: Comparator: sumatriptan
single dose 50 mg sumatriptan p.o.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Relief at 2 Hours After Treatment
Tidsramme: 2 hours after treatment
Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
2 hours after treatment
Time to Relief Within 2 Hours After Treatment
Tidsramme: within 2 hours after treatment
Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
within 2 hours after treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Free at 2 Hours After Treatment
Tidsramme: 2 hours after treatment
Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
2 hours after treatment
Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities
Tidsramme: 2 hours after treatment
Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).
2 hours after treatment
Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment
Tidsramme: 2 hours after treatment
Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.
2 hours after treatment
Participants Who Used Escape Medication 2 Hours After the Treatment Dose
Tidsramme: 2 hours after treatment
Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.
2 hours after treatment
Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])
Tidsramme: 24 hours
Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence
24 hours

Samarbejdspartnere og efterforskere

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

Sponsor

Organon and Co

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. august 1995

Primær færdiggørelse (Faktiske)

1. maj 1996

Studieafslutning (Faktiske)

1. september 1996

Datoer for studieregistrering

Først indsendt

8. maj 2009

Først indsendt, der opfyldte QC-kriterier

11. maj 2009

Først opslået (Skøn)

12. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0462-029
  • 2009_593

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 rizatriptan benzoate (MK0462)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner