An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia (SLUMBER)
2012년 1월 30일 업데이트: Eli Lilly and Company
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study of the Safety and Efficacy of LY2624803 in Outpatients With Insomnia
The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.
연구 개요
상세 설명
Outpatients with chronic insomnia who participate in this study will be treated in each of four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg, or LY2624803 3 mg.
Neither patients nor investigators will be told what treatments are being given in any treatment period.
A patient who completes all four treatment periods will be treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the periods; and with LY2624803 in either 1 or 2 of the periods.
No patient will receive placebo for all four of the 2-week treatment periods.
All patients will receive LY2624803 for at least one of the four 2-week treatment periods.
During each treatment period, patients will record information each morning about their sleep the night before, and each evening about their functioning since waking up.
Patients will also wear wrist actigraphy devices to record their physical activity.
At the conclusion of each treatment period, patients will answer questions about their sleep, functioning, health, and relative preference for treatments.
연구 유형
중재적
등록 (실제)
643
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35213
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
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Glendale, Arizona, 미국, 85306
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mesa, Arizona, 미국, 85210
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Arkansas
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Little Rock, Arkansas, 미국, 72211
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California
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Burbank, California, 미국, 91505
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Glendale, California, 미국, 91206
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Los Angeles, California, 미국, 90048
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Oceanside, California, 미국, 92056
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Pismo Beach, California, 미국, 93449
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San Diego, California, 미국, 92123
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Santa Rosa, California, 미국, 95405
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Torrance, California, 미국, 90502
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Colorado
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Denver, Colorado, 미국, 80239
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Florida
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Fruitland Park, Florida, 미국, 34731
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Hialeah, Florida, 미국, 33012
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Lauderdale Lakes, Florida, 미국, 33319
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Maitland, Florida, 미국, 32751
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Naples, Florida, 미국, 34110
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Pembroke Pines, Florida, 미국, 33024
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St Petersburg, Florida, 미국, 33707
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Tampa, Florida, 미국, 33607
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Georgia
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Atlanta, Georgia, 미국, 30342
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Suwanee, Georgia, 미국, 30024
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Illinois
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Oak Brook, Illinois, 미국, 60523
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Springfield, Illinois, 미국, 62711
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Indiana
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Terre Haute, Indiana, 미국, 47802
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kentucky
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Crestview Hills, Kentucky, 미국, 41017
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Maryland
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Chevy Chase, Maryland, 미국, 20815
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Massachusetts
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Wellesley Hills, Massachusetts, 미국, 02481
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Michigan
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Sterling Heights, Michigan, 미국, 48314
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Florissant, Missouri, 미국, 63033
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Nevada
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Las Vegas, Nevada, 미국, 89146
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New York
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Bronx, New York, 미국, 10454
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Brooklyn, New York, 미국, 11235
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North Carolina
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Hickory, North Carolina, 미국, 28601
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Raleigh, North Carolina, 미국, 27612
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Winston-Salem, North Carolina, 미국, 27103
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Ohio
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Cincinnati, Ohio, 미국, 45246
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Cleveland, Ohio, 미국, 44122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oregon
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Portland, Oregon, 미국, 97210
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Pennsylvania
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Jenkintown, Pennsylvania, 미국, 19046
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rhode Island
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Lincoln, Rhode Island, 미국, 02865
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Anderson, South Carolina, 미국, 29621
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Memphis, Tennessee, 미국, 38119
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Austin, Texas, 미국, 78756
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dallas, Texas, 미국, 75231
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Antonio, Texas, 미국, 78229
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Washington
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Bellevue, Washington, 미국, 98004
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Lakewood, Washington, 미국, 98499
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patients must be between 18 and 85 years of age, with a stable living situation
- Clinical diagnosis of either primary insomnia or "secondary" insomnia (comorbid with depression, anxiety, and/or medical illness)
- Insomnia systems must be at least moderate in severity within the month prior to study entry, and must include difficulty staying asleep and/or problems with awakening earlier than desired
- Psychiatric and medical conditions present must be stable over the 3 months prior to study entry, and not expected to worsen significantly or require hospitalization during participation in the study
- Ongoing treatments for psychiatric and medical conditions present must have been stable for the 3 months prior to study entry, and must be expected to remain stable during participation in the study
- Patients must be willing to abstain from taking medications (other than study drug) to help them sleep during participation in the study
- Patients must be willing to consistently spend at least 7 hours each night either sleeping or trying to sleep during participation in the study
- Patients must be able to speak and read English and be capable of using a computer with a web browser (computers with internet connections will be provided to patients who need them)
Exclusion Criteria:
- Unusual or unstable sleep/wake schedule, such as with rotating shift work
- Severe or unstable psychiatric or medical illness
- Suicidal ideation
- Substance abuse
- Known obstructive sleep apnea, restless leg syndrome, or periodic limb movement disorder
- History of seizures
- Body Mass Index > 33
- Clinically significant abnormality in clinical chemistry, hematology, urinalysis, and/or electrocardiogram
- Anticipated inability to regularly use a medication which might reduce motor or cognitive functioning during sleeping hours, such as a person who might often need to be "on call", drive a car, or be responsible for the care of another person during sleeping hours
- Contraindication to zolpidem
- History of breast cancer
- An estimated glomerular filtration rate (GFR; an index of renal function) that is <30 mL/min at study entry
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Period A
2-week double-blind placebo lead-in period.
Period A is the first of four 2-week treatment periods.
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matching placebo (capsule or tablet), once nightly before bedtime
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실험적: Period B
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods.
Period B is the second of four 2-week treatment periods.
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matching placebo (capsule or tablet), once nightly before bedtime
1 mg, oral capsule, once nightly before bedtime
3 mg, oral capsule, once nightly before bedtime
5 or 10 mg, oral tablet, once nightly before bedtime
|
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실험적: Period C
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods.
Period C is the third of four 2-week treatment periods.
|
matching placebo (capsule or tablet), once nightly before bedtime
1 mg, oral capsule, once nightly before bedtime
3 mg, oral capsule, once nightly before bedtime
5 or 10 mg, oral tablet, once nightly before bedtime
|
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실험적: Period D
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods.
Period D is the fourth of four 2-week treatment periods.
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matching placebo (capsule or tablet), once nightly before bedtime
1 mg, oral capsule, once nightly before bedtime
3 mg, oral capsule, once nightly before bedtime
5 or 10 mg, oral tablet, once nightly before bedtime
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
Total Sleep Time is defined as time in bed minus total time awake.
Minimum would be 0; no defined maximum (except if as defined as time in bed).
The higher the number, the more time asleep.
Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks).
Change score subtracts Period B average from Period A average (baseline).
Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
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Baseline, 2 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed).
Minimum would be 0; no defined maximum.
The higher the number, the more the unwanted time awake.
Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.)
across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline).
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.
|
Baseline, 2 weeks
|
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Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks).
Change score subtracts Period B average from Period A average (baseline).
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
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Baseline, 2 weeks
|
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Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks).
Change score subtracts Period B average from Period A average (baseline).
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
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Baseline, 2 weeks
|
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Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake.
Higher score indicates better sleep efficiency.
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
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Baseline, 2 weeks
|
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Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24.
Sleep experience score ranges from 0-9; awakening experience ranges from 0-15.
The higher the score, the better the sleep.
Scale is averaged across study Period B (2 weeks).
Change score subtracts Period B average from Period A average (baseline).
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
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Baseline, 2 weeks
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Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia).
Scale is averaged across study Period B (2 weeks).
Change score subtracts Period B average from Period A average (baseline).
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
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Baseline, 2 weeks
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Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia.
7 questions on 5-point Likert scale with minimum of 0 and maximum of 28.
The higher the score, the more severe the insomnia.
It was collected at the bi-weekly office visits.
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
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Baseline, 2 weeks
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Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits.
Each score ranges from 0-100.
The components measure physical and mental health, respectively.
Higher scores are indicative of better function.
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)
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Baseline, 2 weeks
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Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint
기간: Baseline, 2 weeks
|
The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument.
The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood.
The score ranges 0-100.
The higher score indicates a better health state perceived by the participant.
ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
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Baseline, 2 weeks
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Treatment Satisfaction as Measured by the Participant Drug Preference Question
기간: Baseline (Period A) and 2 weeks (Period B)
|
After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed.
Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.
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Baseline (Period A) and 2 weeks (Period B)
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Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
기간: 2 weeks
|
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment.
Scores range from 1 (very much improved) to 7 (very much worse).
Data are presented as percentage of participants in each category.
|
2 weeks
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Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
기간: 2 weeks
|
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment.
The score ranges from 1 (very much improved) to 7 (very much worse).
Data are presented as percentage of participants in each category.
|
2 weeks
|
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Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type
기간: Baseline, 2 weeks
|
Total Sleep Time is defined as time in bed minus total time awake.
Minimum would be 0; no defined maximum (except if as defined as time in bed).
The higher the number, the more time asleep.
Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
|
Baseline, 2 weeks
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type
기간: Baseline through 8 weeks
|
Number of participants with AEs and SAEs.
Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
|
Baseline through 8 weeks
|
|
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group
기간: Baseline, 2 weeks
|
Total Sleep Time is defined as time in bed minus total time awake.
Minimum would be 0; no defined maximum (except if as defined as time in bed).
The higher the number, the more time asleep.
Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
|
Baseline, 2 weeks
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group
기간: Baseline through 8 weeks
|
Number of participants with AEs and SAEs.
Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
|
Baseline through 8 weeks
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
기간: Baseline through 8 weeks
|
Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period.
TEAEs are summarized by study period and treatment group.
TEAEs do not distinguish whether the events were deemed serious.
A summary of non-serious AEs is located in the Reported Adverse Event module.
|
Baseline through 8 weeks
|
|
Number of Participants With Serious Adverse Events (SAEs)
기간: Baseline through 8 weeks
|
SAEs do not distinguish whether the events are treatment-emergent.
A summary of SAEs is located in the Reported Adverse Event module.
|
Baseline through 8 weeks
|
|
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
기간: Baseline, 2 weeks of treatment over 8 weeks
|
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented.
Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
|
Baseline, 2 weeks of treatment over 8 weeks
|
|
Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
기간: Baseline, 2 weeks of treatment over 8 weeks
|
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented.
Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
|
Baseline, 2 weeks of treatment over 8 weeks
|
|
Change From Baseline in Weight at Each 2-week Treatment Endpoint
기간: Baseline, 2 weeks of treatment over 8 weeks
|
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented.
Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
|
Baseline, 2 weeks of treatment over 8 weeks
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
기간: 2 weeks of treatment over 8 weeks
|
Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results.
A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period.
All analytes have both lower and upper limits.
The abnormal number includes both low (below normal range) and high (above normal range).
|
2 weeks of treatment over 8 weeks
|
|
Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
기간: Baseline, 2 weeks of treatment over 8 weeks
|
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented.
Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
|
Baseline, 2 weeks of treatment over 8 weeks
|
|
Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
기간: Baseline, 2 weeks of treatment over 8 weeks
|
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle.
QTcF is the QT interval corrected for heart rate using Fridericia formula.
Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
|
Baseline, 2 weeks of treatment over 8 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 10월 1일
기본 완료 (실제)
2010년 2월 1일
연구 완료 (실제)
2010년 2월 1일
연구 등록 날짜
최초 제출
2008년 10월 31일
QC 기준을 충족하는 최초 제출
2008년 10월 31일
처음 게시됨 (추정)
2008년 11월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 2월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 1월 30일
마지막으로 확인됨
2012년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 12063
- I2K-MC-ZZAD (기타 식별자: Eli Lilly and Company)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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