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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00580294
Eligibility Criteria:
Inclusion Criteria:
* Age of 18 to no upper limit
* Chronic pain of nociceptive, neuropathic, or mixed origin
* Patients with chronic non cancer pain
* Ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone)
* Pain of moderate intensity (\>4, on the numerical scale 0-10) despite ongoing opioid therapy\>
* Non-pregnant, non-lactating women
* Sufficient language skills to communicate with research staff
Exclusion Criteria:Non-ambulatory patients
* Clinically significant respiratory, renal, hepatic, or cardiac disease.
* Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea)
* History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors
* Severe depression (\> 26 on the BDI)
* Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).
* Workman compensation, current or pending medical-legal litigation
* Hypersensitivity to study medication (oxymorphone)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00580294
Study Brief:
Protocol Section:
NCT00580294