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View Clinical Trial (Medical Research Study)
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An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia - NCT00784875-11235 (Clinical Trial 250712)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy250712.aspx
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| City: |
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Brooklyn |
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State:
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NY |
| Zip Code: |
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11235 |
| Conditions: |
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Primary Insomnia - Secondary Insomnia |
| Purpose: |
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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.
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| Study summary: |
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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. 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. |
| 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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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