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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. september 2018 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

460

Fase

  • Fase 3

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

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

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
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Esmirtazapine 4.5 mg
Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months
Legemiddel: Esmirtazapine
One esmirtazapine 4.5 mg tablet once a day
Placebo komparator: Placebo
Participants receive placebo tablets, administered once a day for 6 months
Legemiddel: Placebo
One placebo tablet once a day

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Who Experienced Adverse Events (AEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Merck Sharp & Dohme LLC

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.

Generelle publikasjoner

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 (Faktiske)

4. mars 2008

Primær fullføring (Faktiske)

19. november 2009

Studiet fullført (Faktiske)

19. november 2009

Datoer for studieregistrering

Først innsendt

29. februar 2008

Først innsendt som oppfylte QC-kriteriene

29. februar 2008

Først lagt ut (Anslag)

10. mars 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2018

Sist bekreftet

1. september 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P05701
  • 21106 (Annen identifikator: Organon Protocol Number)
  • 2007-005236-92 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

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