- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01654250
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
4. januar 2016 oppdatert av: 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
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
90
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72211
- Clinical Study Centers, LLC
-
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California
-
Huntington Beach, California, Forente stater, 92646
- Laboratory School
-
Irvine, California, Forente stater, 92612
- UC Irvine Child Development Center
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Irvine, California, Forente stater, 92697
- UC Irvine - Hewitt Hall
-
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Florida
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Bradenton, Florida, Forente stater, 34201
- Florida Clinical Research Center, LLC
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Bradenton, Florida, Forente stater, 34202
- Woodland Community Church (Laboratory School)
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Nevada
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Las Vegas, Nevada, Forente stater, 89128
- Center for Psychiatry and Behavioral Medicine, Inc.
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-
Texas
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Houston, Texas, Forente stater, 77007
- Bayou City Research, Ltd.
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Lubbock, Texas, Forente stater, 79423
- Westex Clinical Investigations
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 12 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
|
Placebo
|
Eksperimentell: Active
NWP09
|
Methylphenidate, variable dose, daily dosing, 1 week duration
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points
Tidsramme: 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.
|
0.75 up to 13 hours post-dose
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Onset and Duration of Clinical Effect
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
0.75, 2, 4, 8, 10, 12 and 13 post-dose
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Clinical Global Impression of Severity (CGI-S)
Tidsramme: 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.
|
Baseline, Day 8, 15, 22, 29, 36, 43
|
Clinical Global Impression-Improvement (CGI-I)
Tidsramme: 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.
|
Day 8, 15, 22, 29, 36, 43
|
Conners Parent Rating Scale (CPRS) Scores
Tidsramme: Baseline, Day 8, 15, 22, 29, 36, 43
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2012
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
27. april 2012
Først innsendt som oppfylte QC-kriteriene
26. juli 2012
Først lagt ut (Anslag)
31. juli 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. januar 2016
Sist bekreftet
1. januar 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NWP09-ADHD-300
- B7491005 (Annen identifikator: Alias Study Number)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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-
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