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Migraine Study in Adolescent Patients

30 de novembro de 2016 atualizado por: GlaxoSmithKline

TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a ~25 week period.

Tipo de estudo

Intervencional

Inscrição (Real)

589

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85234
        • GSK Investigational Site
      • Litchfield Park, Arizona, Estados Unidos, 85340
        • GSK Investigational Site
      • Phoenix, Arizona, Estados Unidos, 85013
        • GSK Investigational Site
      • Phoenix, Arizona, Estados Unidos, 85016
        • GSK Investigational Site
      • Phoenix, Arizona, Estados Unidos, 85014
        • GSK Investigational Site
    • Arkansas
      • Conway, Arkansas, Estados Unidos, 72034
        • GSK Investigational Site
      • Little Rock, Arkansas, Estados Unidos, 72205
        • GSK Investigational Site
      • Little Rock, Arkansas, Estados Unidos, 72202
        • GSK Investigational Site
    • California
      • Chico, California, Estados Unidos, 95926
        • GSK Investigational Site
      • Fresno, California, Estados Unidos, 93720
        • GSK Investigational Site
      • Fullteron, California, Estados Unidos, 92835
        • GSK Investigational Site
      • Huntington Beach, California, Estados Unidos, 92647
        • GSK Investigational Site
      • Newport Beach, California, Estados Unidos, 92660
        • GSK Investigational Site
      • Roseville, California, Estados Unidos, 95678
        • GSK Investigational Site
      • Sacramento, California, Estados Unidos, 95816
        • GSK Investigational Site
      • Sacramento, California, Estados Unidos, 95815
        • GSK Investigational Site
      • San Francisco, California, Estados Unidos, 94109
        • GSK Investigational Site
      • Santa Monica, California, Estados Unidos, 90404
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80907
        • GSK Investigational Site
    • Connecticut
      • Fairfield, Connecticut, Estados Unidos, 06824
        • GSK Investigational Site
    • Florida
      • Gainesville, Florida, Estados Unidos, 32607
        • GSK Investigational Site
      • Hialeah, Florida, Estados Unidos, 33010
        • GSK Investigational Site
      • Miami, Florida, Estados Unidos, 33155-3009
        • GSK Investigational Site
      • Pensacola, Florida, Estados Unidos, 32504
        • GSK Investigational Site
      • West Palm Beach, Florida, Estados Unidos, 33407
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • GSK Investigational Site
      • Savannah, Georgia, Estados Unidos, 31405
        • GSK Investigational Site
      • Stockbridge, Georgia, Estados Unidos, 30281
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60642
        • GSK Investigational Site
      • Oak Lawn, Illinois, Estados Unidos, 60453
        • GSK Investigational Site
      • Park Ridge, Illinois, Estados Unidos, 60068
        • GSK Investigational Site
    • Indiana
      • Anderson, Indiana, Estados Unidos, 46011
        • GSK Investigational Site
      • Terre Haute, Indiana, Estados Unidos, 47802
        • GSK Investigational Site
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • GSK Investigational Site
      • Wichita, Kansas, Estados Unidos, 67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, Estados Unidos, 40004
        • GSK Investigational Site
      • Lexington, Kentucky, Estados Unidos, 40509
        • GSK Investigational Site
    • Maryland
      • Pikesville, Maryland, Estados Unidos, 21208
        • GSK Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, Estados Unidos, 01605
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48104
        • GSK Investigational Site
    • Minnesota
      • Plymouth, Minnesota, Estados Unidos, 55441
        • GSK Investigational Site
    • Missouri
      • Springfield, Missouri, Estados Unidos, 65807
        • GSK Investigational Site
      • St. Louis, Missouri, Estados Unidos, 63141
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68130
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, Estados Unidos, 89014
        • GSK Investigational Site
    • New Jersey
      • Vorhees, New Jersey, Estados Unidos, 08043
        • GSK Investigational Site
      • Willingboro, New Jersey, Estados Unidos, 08046
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87108
        • GSK Investigational Site
    • New York
      • Amherst, New York, Estados Unidos, 14226
        • GSK Investigational Site
      • Mineola, New York, Estados Unidos, 11501
        • GSK Investigational Site
      • Mount Vernon, New York, Estados Unidos, 10550
        • GSK Investigational Site
      • Schenectady, New York, Estados Unidos, 12308
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Estados Unidos, 27607
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • GSK Investigational Site
      • Cincinnati, Ohio, Estados Unidos, 45245
        • GSK Investigational Site
      • Cleveland, Ohio, Estados Unidos, 44195
        • GSK Investigational Site
      • West Chester, Ohio, Estados Unidos, 45069
        • GSK Investigational Site
      • Westerville, Ohio, Estados Unidos, 43081
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73112
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, Estados Unidos, 97401
        • GSK Investigational Site
      • Portland, Oregon, Estados Unidos, 97210
        • GSK Investigational Site
      • Salem, Oregon, Estados Unidos, 97301
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19139
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Estados Unidos, 15236
        • GSK Investigational Site
    • South Carolina
      • Greer, South Carolina, Estados Unidos, 29651
        • GSK Investigational Site
      • Simpsonville, South Carolina, Estados Unidos, 29681
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, Estados Unidos, 37620
        • GSK Investigational Site
      • Clarksville, Tennessee, Estados Unidos, 37043
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, Estados Unidos, 75230
        • GSK Investigational Site
      • Houston, Texas, Estados Unidos, 77030-2303
        • GSK Investigational Site
      • San Antonio, Texas, Estados Unidos, 78258
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84107
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22902
        • GSK Investigational Site
      • Norfolk, Virginia, Estados Unidos, 23510
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, Estados Unidos, 98195-6097
        • GSK Investigational Site
      • Vancouver, Washington, Estados Unidos, 98686
        • GSK Investigational Site
      • Wenatchee, Washington, Estados Unidos, 98801
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53715
        • GSK Investigational Site
      • Middleton, Wisconsin, Estados Unidos, 53562-2215
        • GSK Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 17 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the following criteria:

  1. Subject is >/=12 years of age and </=17 years of age at the Screening Visit.
  2. Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least two, but no more than eight attacks per month, for the six months prior to the Screening Visit is required. Attacks should last a minimum of three hours and be associated with moderate-to-severe headache pain.
  3. Subject is able to distinguish migraine from other headaches (i.e., tension-type headaches).

  4. Male or female subjects. Female subjects are eligible for participation in the study if they are:

    1. Females of non-childbearing potential; or
    2. Females of childbearing potential, and who have a negative urine pregnancy test at screening, and agree to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy
  5. Any subject taking oral contraceptives at enrollment must be on a stable regimen for at least 2 months prior to screening.
  6. Subject and subject's parent or legal guardian are able to read and write English or Spanish.
  7. Subject is able to read, comprehend, and complete subject diaries.
  8. Subject's parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.

  9. Subject is willing and able to provide Informed Assent prior to entry into the study (if required).

    -

Exclusion Criteria:

  • Subjects meeting any of the following criteria must not be enrolled in the study:

    1. Subject is < 74 pounds (33.3 kg).
    2. Subject has ≥15 headache days per month in total (migraine, probable migraine, or tension-type), retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic migraine (ICHD-II 1.2.4), or secondary headaches.
    3. Subject, in the investigator's opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.
    4. Subject has uncontrolled hypertension at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
    5. Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
    6. Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs/symptoms consistent with any of the above.
    7. Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
    8. Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
    9. Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.
    10. Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
    11. Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
    12. Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the two weeks prior to screening through two weeks post treatment.
    13. Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
    14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease.
    15. Subject is pregnant, actively trying to become pregnant, or breast feeding or subject is not willing to have pregnancy test(s).
    16. Subject tests positive for illicit substances on toxicology screen, or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
    17. Subject has participated in any investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Placebo para combinar
Medicamento: Placebo
Placebo para combinar
Experimental: Sumatriptan and Naproxen 1
Sumatriptan succinate and naproxen sodium combination 10mg/60mg
Medicamento: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
Experimental: Sumatriptan and Naproxen 2
Sumatriptan succinate and naproxen sodium combination 30mg/180mg
Medicamento: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
Experimental: Sumatriptan and Naproxen 3
Sumatriptan succinate and naproxen sodium combination 85mg/500mg
Medicamento: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Who Were Pain Free at 2 Hours Post-dose
Prazo: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.
2 hours after single dose of double-blind treatment (Randomization through Week 13)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Sustained Pain-free From 2-24 Hours
Prazo: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Photophobia-free at 2 Hours Post-dose
Prazo: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.
2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Phonophobia-free at 2 Hours Post-dose
Prazo: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.
2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Pain-free at 1 Hour Post-dose
Prazo: 1 hour after single dose of double-blind treatment (Randomization through Week 13)
Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.
1 hour after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Photophobia-free From 2-24 Hours
Prazo: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Phonophobia-free From 2-24 Hours
Prazo: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Nausea-free From 2-24 Hours
Prazo: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
Prazo: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Prazo: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.
Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Nausea-free at 2 Hours Post-dose
Prazo: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
The number of participants who did not have nausea at 2 hours post dose was analzyed.
2 hours after single dose of double-blind treatment (Randomization through Week 13)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Mean Age of Participants at Baseline Categorized by Age Group
Prazo: Baseline
The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.
Baseline
Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
Prazo: Baseline
The number of participants receiving double-blind treatment were reported according to age.
Baseline
Number of Female and Male Participants Categorized by Age Group
Prazo: Baseline
The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Baseline
Number of Participants of the Indicated Race Categorized by Age Group
Prazo: Baseline
The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Baseline
Mean Weight of Participants at Baseline Categorized by Age Group
Prazo: Baseline
The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.
Baseline
Mean Body Mass Index of Participants at Baseline Categorized by Age Group
Prazo: Baseline
The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2).
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

GlaxoSmithKline

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de dezembro de 2008

Conclusão Primária (Real)

1 de maio de 2010

Conclusão do estudo (Real)

1 de junho de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

12 de fevereiro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de fevereiro de 2009

Primeira postagem (Estimativa)

13 de fevereiro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

18 de janeiro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de novembro de 2016

Última verificação

1 de novembro de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 107979

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dados/documentos do estudo

  1. Especificação do conjunto de dados
    Identificador de informação: 107979
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plano de Análise Estatística
    Identificador de informação: 107979
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocolo de estudo
    Identificador de informação: 107979
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formulário de Consentimento Informado
    Identificador de informação: 107979
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulário de Relato de Caso Anotado
    Identificador de informação: 107979
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Conjunto de dados de participantes individuais
    Identificador de informação: 107979
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  7. Relatório de Estudo Clínico
    Identificador de informação: 107979
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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