An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia (SLUMBER)
2012. január 30. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
643
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Alabama
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Birmingham, Alabama, Egyesült Államok, 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, Egyesült Államok, 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, Egyesült Államok, 85210
- 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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Arkansas
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Little Rock, Arkansas, Egyesült Államok, 72211
- 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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California
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Burbank, California, Egyesült Államok, 91505
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Glendale, California, Egyesült Államok, 91206
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Los Angeles, California, Egyesült Államok, 90048
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Oceanside, California, Egyesült Államok, 92056
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Pismo Beach, California, Egyesült Államok, 93449
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San Diego, California, Egyesült Államok, 92123
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Santa Rosa, California, Egyesült Államok, 95405
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Torrance, California, Egyesült Államok, 90502
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Colorado
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Denver, Colorado, Egyesült Államok, 80239
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Florida
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Fruitland Park, Florida, Egyesült Államok, 34731
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Hialeah, Florida, Egyesült Államok, 33012
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Lauderdale Lakes, Florida, Egyesült Államok, 33319
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Maitland, Florida, Egyesült Államok, 32751
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Naples, Florida, Egyesült Államok, 34110
- 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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Pembroke Pines, Florida, Egyesült Államok, 33024
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St Petersburg, Florida, Egyesült Államok, 33707
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Tampa, Florida, Egyesült Államok, 33607
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Georgia
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Atlanta, Georgia, Egyesült Államok, 30342
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Suwanee, Georgia, Egyesült Államok, 30024
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Illinois
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Oak Brook, Illinois, Egyesült Államok, 60523
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Springfield, Illinois, Egyesült Államok, 62711
- 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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Indiana
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Terre Haute, Indiana, Egyesült Államok, 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, Egyesült Államok, 41017
- 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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Maryland
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Chevy Chase, Maryland, Egyesült Államok, 20815
- 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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Massachusetts
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Wellesley Hills, Massachusetts, Egyesült Államok, 02481
- 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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Michigan
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Sterling Heights, Michigan, Egyesült Államok, 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, Egyesült Államok, 63033
- 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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Nevada
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Las Vegas, Nevada, Egyesült Államok, 89146
- 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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New York
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Bronx, New York, Egyesült Államok, 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, Egyesült Államok, 11235
- 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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North Carolina
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Hickory, North Carolina, Egyesült Államok, 28601
- 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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Raleigh, North Carolina, Egyesült Államok, 27612
- 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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Winston-Salem, North Carolina, Egyesült Államok, 27103
- 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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Ohio
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Cincinnati, Ohio, Egyesült Államok, 45246
- 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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Cleveland, Ohio, Egyesült Államok, 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, Egyesült Államok, 97210
- 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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Pennsylvania
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Jenkintown, Pennsylvania, Egyesült Államok, 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, Egyesült Államok, 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, Egyesült Államok, 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, Egyesült Államok, 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, Egyesült Államok, 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, Egyesült Államok, 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, Egyesült Államok, 78229
- 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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Washington
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Bellevue, Washington, Egyesült Államok, 98004
- 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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Lakewood, Washington, Egyesült Államok, 98499
- 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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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Period A
2-week double-blind placebo lead-in period.
Period A is the first of four 2-week treatment periods.
|
matching placebo (capsule or tablet), once nightly before bedtime
|
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Kísérleti: 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.
|
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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Kísérleti: 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
|
|
Kísérleti: 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.
|
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
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
Időkeret: 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).
|
Baseline, 2 weeks
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
Időkeret: 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
|
|
Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint
Időkeret: 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).
|
Baseline, 2 weeks
|
|
Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint
Időkeret: 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).
|
Baseline, 2 weeks
|
|
Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint
Időkeret: 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).
|
Baseline, 2 weeks
|
|
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Időkeret: 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).
|
Baseline, 2 weeks
|
|
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
Időkeret: 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).
|
Baseline, 2 weeks
|
|
Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint
Időkeret: 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).
|
Baseline, 2 weeks
|
|
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
Időkeret: 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
Időkeret: Baseline, 2 weeks
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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
Időkeret: Baseline (Period A) and 2 weeks (Period B)
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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
Időkeret: 2 weeks
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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.
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2 weeks
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Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
Időkeret: 2 weeks
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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.
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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
Időkeret: Baseline, 2 weeks
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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.
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Baseline, 2 weeks
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type
Időkeret: Baseline through 8 weeks
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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.
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Baseline through 8 weeks
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Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group
Időkeret: Baseline, 2 weeks
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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.
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Baseline, 2 weeks
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group
Időkeret: Baseline through 8 weeks
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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.
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Baseline through 8 weeks
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Number of Participants With Treatment Emergent Adverse Events (TEAE)
Időkeret: Baseline through 8 weeks
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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.
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Baseline through 8 weeks
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Number of Participants With Serious Adverse Events (SAEs)
Időkeret: Baseline through 8 weeks
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SAEs do not distinguish whether the events are treatment-emergent.
A summary of SAEs is located in the Reported Adverse Event module.
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Baseline through 8 weeks
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Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Időkeret: Baseline, 2 weeks of treatment over 8 weeks
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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.
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Baseline, 2 weeks of treatment over 8 weeks
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Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
Időkeret: Baseline, 2 weeks of treatment over 8 weeks
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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.
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Baseline, 2 weeks of treatment over 8 weeks
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Change From Baseline in Weight at Each 2-week Treatment Endpoint
Időkeret: Baseline, 2 weeks of treatment over 8 weeks
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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.
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Baseline, 2 weeks of treatment over 8 weeks
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Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Időkeret: 2 weeks of treatment over 8 weeks
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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).
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2 weeks of treatment over 8 weeks
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Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Időkeret: Baseline, 2 weeks of treatment over 8 weeks
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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.
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Baseline, 2 weeks of treatment over 8 weeks
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Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Időkeret: Baseline, 2 weeks of treatment over 8 weeks
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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.
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Baseline, 2 weeks of treatment over 8 weeks
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2008. október 1.
Elsődleges befejezés (Tényleges)
2010. február 1.
A tanulmány befejezése (Tényleges)
2010. február 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2008. október 31.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2008. október 31.
Első közzététel (Becslés)
2008. november 4.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2012. február 29.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2012. január 30.
Utolsó ellenőrzés
2012. január 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Mentális zavarok
- Idegrendszeri betegségek
- Alvászavarok, belső
- Disszomniák
- Alvás-ébrenléti zavarok
- Alváskezdési és -fenntartási zavarok
- A gyógyszerek élettani hatásai
- Neurotranszmitter szerek
- A farmakológiai hatás molekuláris mechanizmusai
- Központi idegrendszer depresszánsai
- Altatók és nyugtatók
- GABA ügynökök
- Alvássegítők, Gyógyszerészeti
- GABA-A receptor agonisták
- GABA agonisták
- Zolpidem
Egyéb vizsgálati azonosító számok
- 12063
- I2K-MC-ZZAD (Egyéb azonosító: Eli Lilly and Company)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .