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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 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

460

Phase

  • Phase 3

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Esmirtazapine 4.5 mg
Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months
Arzneimittel: Esmirtazapine
One esmirtazapine 4.5 mg tablet once a day
Placebo-Komparator: Placebo
Participants receive placebo tablets, administered once a day for 6 months
Arzneimittel: Placebo
One placebo tablet once a day

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Who Experienced Adverse Events (AEs)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Merck Sharp & Dohme LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. März 2008

Primärer Abschluss (Tatsächlich)

19. November 2009

Studienabschluss (Tatsächlich)

19. November 2009

Studienanmeldedaten

Zuerst eingereicht

29. Februar 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Februar 2008

Zuerst gepostet (Schätzen)

10. März 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Oktober 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. September 2018

Zuletzt verifiziert

1. September 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • P05701
  • 21106 (Andere Kennung: Organon Protocol Number)
  • 2007-005236-92 (EudraCT-Nummer)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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