- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02151253
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Receiving standard-of-care therapy for nocturia based on assessment by study physician
- Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
- Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
- Epworth Sleepiness Scale Score of at least 10
- Clinical Global Impression of Sleepiness at least Moderate
- Age 18-90 years inclusive
Exclusion Criteria:
- Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
- Sleep disorders other than nocturia based on history and screening assessment
- Unstable medical or psychiatry conditions
- Medical or psychiatric conditions affecting sleep/wake or urologic function
- Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
- Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
- History of substance abuse or dependence in the last year
- Regular consumption of over 800 mg of caffeine use
- Shift-work in the 3 months prior to or during the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Armodafinil First, Then Placebo
During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am. Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. |
Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am.
Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects.
After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects.
No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills.
Subjects took placebo once daily, before 8 am.
Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects.
After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects.
No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
|
위약 비교기: Placebo First, Then Armodafinil
During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am. Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. |
Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am.
Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects.
After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects.
No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills.
Subjects took placebo once daily, before 8 am.
Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects.
After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects.
No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change From Baseline in Epworth Sleepiness Scale [ESS]
기간: Baseline, Week 4 of each phase
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Epworth sleepiness scale (ESS) is measure of subjective sleepiness.
Tendency to fall asleep in 8 situations.
Total varies from zero to 24.
A ESS of 10 or less is considered normal.
Change is calculated as value at baseline minus value at week 4.
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Baseline, Week 4 of each phase
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
기간: week 4, of each phase
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Scale consists of a 7 point likert rating scale where the anchors were 1= "normal"; 2= "borderline sleepiness"; 3= "mild sleepiness"; 4= "moderate sleepiness"; 5= "marked sleepiness"; 6= "severe sleepiness"; and 7= "among the most extremely sleepy individuals"
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week 4, of each phase
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Mean Number of Naps/Day
기간: week 4 of each phase.
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measurements are for the preceding week
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week 4 of each phase.
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Mean Number of Minutes Napped Per Day Based on Sleep Diary
기간: week 4 of each phase.
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measurements are for the preceding week
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week 4 of each phase.
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Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
기간: week 4 of each phase.
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Nocturic Events is defined as an episode of urination preceded and followed by sleep.
Measurements are for the preceding week
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week 4 of each phase.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Andrew Krystal, MD, Duke University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00028116
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