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An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia

NCT ID: NCT00784875

Last Updated: 2012-02-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

643 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Insomnia Secondary Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Period A

2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo (capsule or tablet), once nightly before bedtime

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.

Group Type EXPERIMENTAL

LY2624803

Intervention Type DRUG

1 mg, oral capsule, once nightly before bedtime

LY2624803

Intervention Type DRUG

3 mg, oral capsule, once nightly before bedtime

Placebo

Intervention Type DRUG

matching placebo (capsule or tablet), once nightly before bedtime

zolpidem

Intervention Type DRUG

5 or 10 mg, oral tablet, once nightly before bedtime

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.

Group Type EXPERIMENTAL

LY2624803

Intervention Type DRUG

1 mg, oral capsule, once nightly before bedtime

LY2624803

Intervention Type DRUG

3 mg, oral capsule, once nightly before bedtime

Placebo

Intervention Type DRUG

matching placebo (capsule or tablet), once nightly before bedtime

zolpidem

Intervention Type DRUG

5 or 10 mg, oral tablet, once nightly before bedtime

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.

Group Type EXPERIMENTAL

LY2624803

Intervention Type DRUG

1 mg, oral capsule, once nightly before bedtime

LY2624803

Intervention Type DRUG

3 mg, oral capsule, once nightly before bedtime

Placebo

Intervention Type DRUG

matching placebo (capsule or tablet), once nightly before bedtime

zolpidem

Intervention Type DRUG

5 or 10 mg, oral tablet, once nightly before bedtime

Interventions

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LY2624803

1 mg, oral capsule, once nightly before bedtime

Intervention Type DRUG

LY2624803

3 mg, oral capsule, once nightly before bedtime

Intervention Type DRUG

Placebo

matching placebo (capsule or tablet), once nightly before bedtime

Intervention Type DRUG

zolpidem

5 or 10 mg, oral tablet, once nightly before bedtime

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Birmingham, Alabama, United States

Site Status

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Glendale, Arizona, United States

Site Status

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Mesa, Arizona, United States

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Little Rock, Arkansas, United States

Site Status

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Burbank, California, United States

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Glendale, California, United States

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Los Angeles, California, United States

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Oceanside, California, United States

Site Status

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Pismo Beach, California, United States

Site Status

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San Diego, California, United States

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Santa Rosa, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Fruitland Park, Florida, United States

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Hialeah, Florida, United States

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Lauderdale Lakes, Florida, United States

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Maitland, Florida, United States

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Naples, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Suwanee, Georgia, United States

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Oak Brook, Illinois, United States

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Springfield, Illinois, United States

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Terre Haute, Indiana, United States

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Crestview Hills, Kentucky, United States

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Chevy Chase, Maryland, United States

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Wellesley Hills, Massachusetts, United States

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Sterling Heights, Michigan, United States

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Florissant, Missouri, United States

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Las Vegas, Nevada, United States

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Brooklyn, New York, United States

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The Bronx, New York, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Jenkintown, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Anderson, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Bellevue, Washington, United States

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Lakewood, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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I2K-MC-ZZAD

Identifier Type: OTHER

Identifier Source: secondary_id

12063

Identifier Type: -

Identifier Source: org_study_id