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- Klinische proef NCT01654250
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
4 januari 2016 bijgewerkt door: Pfizer
A Multicenter, Dose-optimized, Double-blind, Randomized, Placebo-controlled Study To Evaluate The Efficacy Of Nwp09 In Pediatric Patients With Attention Deficit Hyperactivity Disorder (Adhd) In A Laboratory Classroom
The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
90
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72211
- Clinical Study Centers, LLC
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California
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Huntington Beach, California, Verenigde Staten, 92646
- Laboratory School
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Irvine, California, Verenigde Staten, 92612
- UC Irvine Child Development Center
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Irvine, California, Verenigde Staten, 92697
- UC Irvine - Hewitt Hall
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Florida
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Bradenton, Florida, Verenigde Staten, 34201
- Florida Clinical Research Center, LLC
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Bradenton, Florida, Verenigde Staten, 34202
- Woodland Community Church (Laboratory School)
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89128
- Center for Psychiatry and Behavioral Medicine, Inc.
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Texas
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Houston, Texas, Verenigde Staten, 77007
- Bayou City Research, Ltd.
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Lubbock, Texas, Verenigde Staten, 79423
- Westex Clinical Investigations
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 jaar tot 12 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition
Exclusion Criteria:
- Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Placebo
|
Placebo
|
Experimenteel: Active
NWP09
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Methylphenidate, variable dose, daily dosing, 1 week duration
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points
Tijdsspanne: 0.75 up to 13 hours post-dose
|
The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors.
SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13).
The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.
Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.
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0.75 up to 13 hours post-dose
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Onset and Duration of Clinical Effect
Tijdsspanne: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose
|
Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point.
Onset of effect was defined as first assessment time showing statistical significance (i.e.
p was less than or equal to [=<] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo.
SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors.
SKAMP combined score was comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)].
SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.
|
0.75, 2, 4, 8, 10, 12, 13 hours post-dose
|
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose
Tijdsspanne: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose
|
SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors.
The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment).
SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.
SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.
|
0.75, 2, 4, 8, 10, 12, 13 hours post-dose
|
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose
Tijdsspanne: 0.75, 2, 4, 8, 10, 12 and 13 post-dose
|
The PERMP score measured the manifestations of attention deficit hyperactivity disorder.
The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom.
At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant's performance.
The total score range from 0-160 with higher scores indicating better performance.
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0.75, 2, 4, 8, 10, 12 and 13 post-dose
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Clinical Global Impression of Severity (CGI-S)
Tijdsspanne: Baseline, Day 8, 15, 22, 29, 36, 43
|
CGI-S scale was used to measure features associated with ADHD.
The assessment was performed by the investigator of the study research team.
The CGI-S classified the participant's current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants.
This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.
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Baseline, Day 8, 15, 22, 29, 36, 43
|
Clinical Global Impression-Improvement (CGI-I)
Tijdsspanne: Day 8, 15, 22, 29, 36, 43
|
The CGI-I measured the participant's disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse.
This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.
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Day 8, 15, 22, 29, 36, 43
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Conners Parent Rating Scale (CPRS) Scores
Tijdsspanne: Baseline, Day 8, 15, 22, 29, 36, 43
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CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks.
The assessment was performed by parent or guardian.
CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true).
Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems.
The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV).
This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.
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Baseline, Day 8, 15, 22, 29, 36, 43
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2012
Primaire voltooiing (Werkelijk)
1 oktober 2012
Studie voltooiing (Werkelijk)
1 oktober 2012
Studieregistratiedata
Eerst ingediend
27 april 2012
Eerst ingediend dat voldeed aan de QC-criteria
26 juli 2012
Eerst geplaatst (Schatting)
31 juli 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
3 februari 2016
Laatste update ingediend die voldeed aan QC-criteria
4 januari 2016
Laatst geverifieerd
1 januari 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NWP09-ADHD-300
- B7491005 (Andere identificatie: Alias Study Number)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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