Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00374556
Eligibility Criteria:
Inclusion Criteria:
* Age 18-64
* Diagnosed with and under physicians care for osteoarthritis of the knee according to American College of Rheumatology Criteria with radiographic evidence demonstrating at least grade 1 osteoarthritis (OA)
* Report at least typical arthritic pain\>4 out of 10 (0=no pain, 10=the most extreme pain imaginable)
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and International Classification of Sleep Disorders, Revised definition (ICSD-R) criteria for either primary (psychophysiologic) insomnia or insomnia secondary to osteoarthritis
* Insomnia symptoms must include problems with middle of the night awakenings
* Insomnia symptom duration \> 6 months
* Baseline, 2-week, sleep diary average wake after sleep onset time \>30 minutes
* Baseline self-reported total sleep time \< 6.5 hours per night
* Patients taking NSAID therapy for pain must be on a stable dose for a period of at least one month prior to initiating the study
Exclusion Criteria:
* Intrinsic sleep disorders other than insomnia (sleep apnea, periodic limb movement disorder, etc)
* Significant rheumatologic or chronic pain disorders other than osteoarthritis of the knee, including fibromyalgia or the complaint of widespread pain impacting 4 quadrants, complex regional pain syndrome, post herpetic neuralgia, etc)
* Major medical disease (including, hepatic impairment, chronic obstructive pulmonary disease/compromised respiratory function, cancer, dementia, diabetes, congestive heart failure, cerebrovascular disease, raynaud's syndrome)
* Active major psychiatric disorders (including dementia or cognitive impairment) and history of schizophrenia or bipolar I disorder
* History of serious suicide attempt; 6) history of alcohol or substance (including prescription medications) abuse
* Pregnancy or plans to become pregnant within 6 months
* Intraarticular steroid injection within the past month
* Regular (\>3 days/week) use of antidepressants, antipsychotics, and mood stabilizers, within the past two months
* Regular (\> 3/week) use of myorelaxants, narcotics, sedative hypnotics, and anticonvulsants within the past one month
* Unwilling or unable to discontinue all use of the medications listed in #10 for two weeks prior to starting the study
* Unwilling or unable to discontinue all centrally acting agents and all analgesic usage within 24 hours of pain testing sessions
* Refusal to provide consent to contact patient's physician to establish diagnosis and obtain medical record information
* Regular tobacco or nicotine use
* Heavy caffeine use \[(\>2 cups of coffee/day (equivalent)
* History of previous allergic reaction or severe side effects to sedative hypnotics
* Use of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, troleandomycin, ritonavir, nelfinavir)
* In addition, subjects will undergo in-laboratory blood tests prior to receiving drug and will be excluded from further participation if they exhibit: a) positive pregnancy test, b) positive toxicology (benzodiazepine, opioids, Tetrahydrocannabinol (THC), alcohol, and stimulants), c) abnormal liver enzyme panel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00374556
Study Brief:
Protocol Section:
NCT00374556