A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
2018年9月4日 更新者：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).
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
460
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Esmirtazapine 4.5 mg
Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months
|
One esmirtazapine 4.5 mg tablet once a day
|
|
プラセボコンパレーター：Placebo
Participants receive placebo tablets, administered once a day for 6 months
|
One placebo tablet once a day
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Who Experienced Adverse Events (AEs)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2008年3月4日
一次修了 (実際)
2009年11月19日
研究の完了 (実際)
2009年11月19日
試験登録日
最初に提出
2008年2月29日
QC基準を満たした最初の提出物
2008年2月29日
最初の投稿 (見積もり)
2008年3月10日
学習記録の更新
投稿された最後の更新 (実際)
2018年10月2日
QC基準を満たした最後の更新が送信されました
2018年9月4日
最終確認日
2018年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- P05701
- 21106 (その他の識別子：Organon Protocol Number)
- 2007-005236-92 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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