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A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)

4 de setembro de 2018 atualizado por: Merck Sharp & Dohme LLC

A 6-Month, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Outpatient Trial, Investigating the Efficacy and Safety of Org 50081 in Adult Patients With Chronic Primary Insomnia

To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.

The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on TST (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.

The current study is designed to assess the long-term efficacy and safety of esmirtazapine in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in participants suffering from chronic primary insomnia. During the 6-month treatment period, participants are randomly assigned to receive either esmirtazapine or placebo. Then, during the 7-day discontinuation period, participants who received esmirtazapine in the 6-month treatment period are randomly assigned to receive either esmirtazapine or placebo, while participants who received placebo in the 6-month treatment period continue to receive placebo.

Tipo de estudo

Intervencional

Inscrição (Real)

460

Estágio

  • Fase 3

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • are at least 18 and less than 65 years;
  • sign written informed consent after the scope and nature of the investigation have been explained;
  • have shown capability to complete the LogPad questionnaires;
  • have difficulty falling asleep, maintaining sleep or have early morning awakening;

Exclusion Criteria:

  • Significant medical or psychiatric illness causing sleep disturbances.
  • Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.
  • Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.
  • Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.
  • Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.
  • Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.
  • Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.
  • Routinely nap during the day.
  • Have a Body Mass Index (BMI) of 36 or more.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Esmirtazapine 4.5 mg
Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months
Medicamento: Esmirtazapine
One esmirtazapine 4.5 mg tablet once a day
Comparador de Placebo: Placebo
Participants receive placebo tablets, administered once a day for 6 months
Medicamento: Placebo
One placebo tablet once a day

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period
Prazo: Baseline and the Mean of Weeks 14-26
TST was defined as the time recorded for sleep diary question 6 "How much time did you actually spend sleeping?" as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach.
Baseline and the Mean of Weeks 14-26

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Who Experienced Adverse Events (AEs)
Prazo: Up to 31 weeks
An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.
Up to 31 weeks
Number of Participants Who Discontinued Study Drug Due to an AE
Prazo: Up to 27 weeks
An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.
Up to 27 weeks
Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period
Prazo: Baseline and the Mean of Weeks 14-26
SL was defined as the time recorded for sleep diary question 3 "How long did it take you to fall asllep?", as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.
Baseline and the Mean of Weeks 14-26
Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period
Prazo: Baseline and the Mean of Weeks 14-26
WASO was defined as the time recorded for sleep diary question 5 "How much time were you awake, after falling asleep initially?", as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.
Baseline and the Mean of Weeks 14-26

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period
Prazo: Baseline and the Mean of Weeks 14-26
NAW was defined as the number of times recorded for sleep diary question 4a "How many times did you wake up during the night?", as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.
Baseline and the Mean of Weeks 14-26
Change From Baseline in Sleep Quality - 6-Month Treatment Period
Prazo: Baseline and the Mean of Weeks 14-26
Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 "Rate the quality of your sleep last night", as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.
Baseline and the Mean of Weeks 14-26
Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period
Prazo: Baseline and the Mean of Weeks 14-26
Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 "How satisfied are you about your sleep duration of last night?", as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.
Baseline and the Mean of Weeks 14-26
Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period
Prazo: Baseline and Week 26
SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization.
Baseline and Week 26
Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period
Prazo: Baseline and Week 26
The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment.
Baseline and Week 26
Change From Baseline in Investigator Global Rating (IGR) - 7-Day Discontinuation Period
Prazo: Baseline and End of 7-day Discontinuation Period
The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 7-day Discontinuation Period to assess the effects of discontinuing treatment.
Baseline and End of 7-day Discontinuation Period

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Merck Sharp & Dohme LLC

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de março de 2008

Conclusão Primária (Real)

19 de novembro de 2009

Conclusão do estudo (Real)

19 de novembro de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

29 de fevereiro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de fevereiro de 2008

Primeira postagem (Estimativa)

10 de março de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de outubro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de setembro de 2018

Última verificação

1 de setembro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • P05701
  • 21106 (Outro identificador: Organon Protocol Number)
  • 2007-005236-92 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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