- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01654250
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
4 gennaio 2016 aggiornato da: 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
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
90
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
-
-
Arkansas
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Little Rock, Arkansas, Stati Uniti, 72211
- Clinical Study Centers, LLC
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California
-
Huntington Beach, California, Stati Uniti, 92646
- Laboratory School
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Irvine, California, Stati Uniti, 92612
- UC Irvine Child Development Center
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Irvine, California, Stati Uniti, 92697
- UC Irvine - Hewitt Hall
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Florida
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Bradenton, Florida, Stati Uniti, 34201
- Florida Clinical Research Center, LLC
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Bradenton, Florida, Stati Uniti, 34202
- Woodland Community Church (Laboratory School)
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89128
- Center for Psychiatry and Behavioral Medicine, Inc.
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Texas
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Houston, Texas, Stati Uniti, 77007
- Bayou City Research, Ltd.
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Lubbock, Texas, Stati Uniti, 79423
- Westex Clinical Investigations
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-
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 6 anni a 12 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
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
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Placebo
|
Placebo
|
Sperimentale: Active
NWP09
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Methylphenidate, variable dose, daily dosing, 1 week duration
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Onset and Duration of Clinical Effect
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Clinical Global Impression of Severity (CGI-S)
Lasso di tempo: 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
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Clinical Global Impression-Improvement (CGI-I)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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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 luglio 2012
Completamento primario (Effettivo)
1 ottobre 2012
Completamento dello studio (Effettivo)
1 ottobre 2012
Date di iscrizione allo studio
Primo inviato
27 aprile 2012
Primo inviato che soddisfa i criteri di controllo qualità
26 luglio 2012
Primo Inserito (Stima)
31 luglio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
3 febbraio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 gennaio 2016
Ultimo verificato
1 gennaio 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NWP09-ADHD-300
- B7491005 (Altro identificatore: Alias Study Number)
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 .