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A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

5 września 2019 zaktualizowane przez: Eli Lilly and Company

Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome

The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).

This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

184

Faza

  • Faza 3

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Argentyna
      • San Miguel De Tucuman, Argentyna, T4000AXL
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Indie
      • Chennai, Indie, 600003
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hyderabad, Indie, 500034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mysore, Indie, 570004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Raipur, Indie, 492001
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Portoryko
      • San Juan, Portoryko, 00912
        • Centro de Investigaciones Clinicas
      • San Juan, Portoryko, 00926
        • Centro Pediatrico Paseos
  • Stany Zjednoczone
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85032
        • NoesisPharma
    • California
      • Loma Linda, California, Stany Zjednoczone, 92354
        • Loma Linda University School of Medicine
      • National City, California, Stany Zjednoczone, 91950
        • Synergy Clinical Research
    • Connecticut
      • Cromwell, Connecticut, Stany Zjednoczone, 06416
        • Connecticut Clinical Trials LLC
      • Fairfield, Connecticut, Stany Zjednoczone, 06824
        • Associated Neurologists of Southern Connecticut
    • Florida
      • West Palm Beach, Florida, Stany Zjednoczone, 33409
        • Palm Beach Research Center
    • Georgia
      • Smyrna, Georgia, Stany Zjednoczone, 30080
        • Institute For Behavioral Medicine
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46202
        • Riley Hosptial for Children
    • Kentucky
      • Lexington, Kentucky, Stany Zjednoczone, 40504
        • Kentucky Medical Research Center
    • Missouri
      • Saint Louis, Missouri, Stany Zjednoczone, 63141
        • Mercy Health Research
    • New Hampshire
      • Nashua, New Hampshire, Stany Zjednoczone, 03060
        • Healthy Perspectives Innovative Mental Health Services, PL
    • New Mexico
      • Albuquerque, New Mexico, Stany Zjednoczone, 87109
        • Albuquerque Neurosciences
    • New York
      • Mount Kisco, New York, Stany Zjednoczone, 10549
        • Bioscience Research, LLC
      • Staten Island, New York, Stany Zjednoczone, 10312
        • Richmond Behavorial Associates
    • Ohio
      • Canton, Ohio, Stany Zjednoczone, 44718
        • Neurobehavioral Clinical Research
      • Cincinnati, Ohio, Stany Zjednoczone, 45219
        • Univ of Cincinnati College of Medicine
      • Middleburg Heights, Ohio, Stany Zjednoczone, 44130
        • North Star Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73109
        • Neuropsychiatric Center
    • Pennsylvania
      • Duncansville, Pennsylvania, Stany Zjednoczone, 16635
        • Altoona Center for Clinical Research
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19139
        • CRI Lifetree
    • Tennessee
      • Kingsport, Tennessee, Stany Zjednoczone, 37660
        • Holston Medical Group Clinical Research
    • Texas
      • San Antonio, Texas, Stany Zjednoczone, 78232
        • Arthritis and Osteoporosis Center of South Texas
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84102
        • Bateman Horne Center of Excellence
    • Virginia
      • Herndon, Virginia, Stany Zjednoczone, 20170-2613
        • Neuroscience, Inc.
      • Virginia Beach, Virginia, Stany Zjednoczone, 23505
        • Advanced Pain Management
    • Washington
      • Bellevue, Washington, Stany Zjednoczone, 98007-4209
        • Northwest Clinical Research Center

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

13 lat do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria

  • Meet criteria for primary JPFS
  • Have a score of greater than or equal to 4 on Brief Pain Inventory (BPI) average pain severity (Item 3) during screening
  • Female participants must have a negative serum pregnancy test during screening
  • Participant's parent/legal representative and participant judged to be reliable to keep all appointments for clinical tests and procedures
  • Participant's parent/legal representative and participant must have a degree of understanding such that they can communicate intelligently
  • Participants must be capable of swallowing investigational product whole
  • Participants must have venous access sufficient to allow blood sampling and be compliant with blood draws

Exclusion Criteria:

  • Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device or concurrently enrolled in any other type of medical research
  • Previously completed or withdrawn after randomization from a study investigating duloxetine
  • Known hypersensitivity to duloxetine or any of the inactive ingredients, or have frequent or severe allergic reactions to multiple medications
  • Treated with duloxetine within the last 6 months. Will not likely benefit from duloxetine treatment, in the opinion of the investigator or have had prior nonresponse or inadequate tolerance to duloxetine
  • Pain symptoms related to traumatic injury, past surgery, structural bone or joint disease or regional pain syndrome that will interfere with interpretation of outcome measures
  • Currently have evidence of rheumatologic disorder or have a current diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (for example, systemic lupus erythematosus)
  • Have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I condition, currently or within the past year, except major depressive disorder (MDD) and/or generalized anxiety disorder (GAD), adjustment disorder or specific phobias with primary investigator approval
  • Have a current secondary DSM-IV Axis I condition of attention-deficit/hyperactivity disorder that requires pharmacologic treatment
  • Lifetime DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
  • DSM-IV Axis II disorder which would interfere with protocol compliance
  • History of substance abuse or dependence within the 6 months
  • Positive urine drug screen for any substances of abuse or excluded medication
  • Family history of 1 or more first-degree relatives with diagnosed bipolar I disorder
  • Significant suicide attempt within 1 year of screening or are currently at suicidal risk in the opinion of the investigator
  • Weight less than 20 kilogram (kg) at screening
  • History of seizure disorder (other than febrile seizures)
  • Taking any excluded medications that cannot be discontinued at screening
  • Fluoxetine within 30 days prior to completion of screening
  • Monoamine oxidase inhibitor (MAOI) within 14 days of screening; or the potential need to use an MAOI during the study or within 5 days of discontinuation of investigational product
  • Abnormal thyroid-stimulating hormone (TSH) concentrations
  • Uncontrolled narrow-angle glaucoma
  • Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C)
  • Serious or unstable medical illness
  • Female participants who are either pregnant, nursing or have recently given birth

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: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Duloxetine

Blinded treatment period: 30mg or 60mg once daily for 13 weeks

Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks

Taper period: 30mg Duloxetine or placebo once daily for 1 week.
Lek: Duloksetyna
Podawany doustnie
Inne nazwy:
  • LY248686
Komparator placebo: Placebo

Blinded treatment period:Placebo once daily for 13 weeks

Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks

Taper period: 30mg Duloxetine or placebo once daily for 1 week.
Lek: Placebo
Podawany doustnie
Lek: Duloksetyna
Podawany doustnie
Inne nazwy:
  • LY248686

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
Ramy czasowe: Baseline, 13 weeks

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means.
Baseline, 13 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items
Ramy czasowe: Baseline, 13 weeks

The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.

MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means.
Baseline, 13 weeks
Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
Ramy czasowe: Baseline (Extension Phase), 39 weeks

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase.
Baseline (Extension Phase), 39 weeks
Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
Ramy czasowe: 13 weeks

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF).
13 weeks
Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
Ramy czasowe: 13 weeks

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF).
13 weeks
Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
Ramy czasowe: Baseline, 13 weeks

Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
Ramy czasowe: Baseline, 13 weeks

Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
Ramy czasowe: Baseline, 13 weeks

Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)
Ramy czasowe: Baseline, 13 weeks

Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)
Ramy czasowe: Baseline, 13 weeks

Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Children's Depression Inventory (CDI)
Ramy czasowe: Baseline, 13 weeks

Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
Ramy czasowe: Baseline, 13 weeks
Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items
Ramy czasowe: Baseline (extension phase), 39 weeks

The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
Ramy czasowe: Baseline (extension phase), 39 weeks

Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
Ramy czasowe: Baseline (extension phase), 39 weeks

Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
Ramy czasowe: Baseline (extension phase), 39 weeks

Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Functional Disability Inventory Child Form (FDI-child)
Ramy czasowe: Baseline (extension phase), 39 weeks

Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)
Ramy czasowe: Baseline (extension phase), 39 weeks

Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Children's Depression Inventory (CDI)
Ramy czasowe: Baseline (extension phase), 39 weeks

Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
Ramy czasowe: Baseline (extension phase), 39 weeks
Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Eli Lilly and Company

Śledczy

  • Dyrektor Studium: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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 marca 2011

Zakończenie podstawowe (Rzeczywisty)

31 maja 2017

Ukończenie studiów (Rzeczywisty)

28 listopada 2017

Daty rejestracji na studia

Pierwszy przesłany

8 listopada 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 listopada 2010

Pierwszy wysłany (Oszacować)

9 listopada 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 września 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 września 2019

Ostatnia weryfikacja

1 września 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 14099 (Inny identyfikator: City of Hope Medical Center)
  • F1J-MC-HMGW (Inny identyfikator: Eli Lilly and Company)
  • CTRI/2011/07/001866 (Identyfikator rejestru: Clinical Trials Registry India)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Ramy czasowe udostępniania IPD

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Kryteria dostępu do udostępniania IPD

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • CSR

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 .

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Warunki

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