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Migraine Study in Adolescent Patients

30 listopada 2016 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

589

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

12 lat do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Placebo do dopasowania
Lek: Placebo
Placebo do dopasowania
Eksperymentalny: Sumatriptan and Naproxen 1
Sumatriptan succinate and naproxen sodium combination 10mg/60mg
Lek: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
Eksperymentalny: Sumatriptan and Naproxen 2
Sumatriptan succinate and naproxen sodium combination 30mg/180mg
Lek: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
Eksperymentalny: Sumatriptan and Naproxen 3
Sumatriptan succinate and naproxen sodium combination 85mg/500mg
Lek: Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Who Were Pain Free at 2 Hours Post-dose
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Sustained Pain-free From 2-24 Hours
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Mean Age of Participants at Baseline Categorized by Age Group
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

GlaxoSmithKline

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 2008

Zakończenie podstawowe (Rzeczywisty)

1 maja 2010

Ukończenie studiów (Rzeczywisty)

1 czerwca 2010

Daty rejestracji na studia

Pierwszy przesłany

12 lutego 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 lutego 2009

Pierwszy wysłany (Oszacować)

13 lutego 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

18 stycznia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 listopada 2016

Ostatnia weryfikacja

1 listopada 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 107979

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Badanie danych/dokumentów

  1. Specyfikacja zestawu danych
    Identyfikator informacji: 107979
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plan analizy statystycznej
    Identyfikator informacji: 107979
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protokół badania
    Identyfikator informacji: 107979
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formularz świadomej zgody
    Identyfikator informacji: 107979
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formularz zgłoszenia przypadku z adnotacjami
    Identyfikator informacji: 107979
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  6. Indywidualny zestaw danych uczestnika
    Identyfikator informacji: 107979
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  7. Raport z badania klinicznego
    Identyfikator informacji: 107979
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Placebo

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Warunki

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Lokalizacje

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