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Migraine Study in Adolescent Patients

30 novembre 2016 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

589

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Placebo da abbinare
Droga: Placebo
Placebo da abbinare
Sperimentale: Sumatriptan and Naproxen 1
Sumatriptan succinate and naproxen sodium combination 10mg/60mg
Droga: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
Sperimentale: Sumatriptan and Naproxen 2
Sumatriptan succinate and naproxen sodium combination 30mg/180mg
Droga: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
Sperimentale: Sumatriptan and Naproxen 3
Sumatriptan succinate and naproxen sodium combination 85mg/500mg
Droga: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Who Were Pain Free at 2 Hours Post-dose
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Sustained Pain-free From 2-24 Hours
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Age of Participants at Baseline Categorized by Age Group
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2008

Completamento primario (Effettivo)

1 maggio 2010

Completamento dello studio (Effettivo)

1 giugno 2010

Date di iscrizione allo studio

Primo inviato

12 febbraio 2009

Primo inviato che soddisfa i criteri di controllo qualità

12 febbraio 2009

Primo Inserito (Stima)

13 febbraio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 gennaio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 novembre 2016

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 107979

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Dati/documenti di studio

  1. Specifica del set di dati
    Identificatore informazioni: 107979
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Piano di analisi statistica
    Identificatore informazioni: 107979
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocollo di studio
    Identificatore informazioni: 107979
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Modulo di consenso informato
    Identificatore informazioni: 107979
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 107979
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Set di dati del singolo partecipante
    Identificatore informazioni: 107979
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Rapporto di studio clinico
    Identificatore informazioni: 107979
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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