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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT00911261
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either:
1. have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or
2. have intolerable side effects to one or more components of their current opioid-containing analgesic regimen.
* Currently receive a stable (at least 2 weeks duration) analgesic regimen
* If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method).
* Understand written and spoken English
* Have been informed of the nature of the study and provided written informed consent
Additional Inclusion Criteria for Cancer Patients Only:
* Have a life expectancy of at least 12 months
Additional Inclusion Criteria for Neuropathic Patients Only:
* Have a diagnosis of:
* post-herpetic neuralgia (PHN)
* diabetic neuropathy (DN)
* complex regional pain syndrome (CRPS)
* HIV neuropathy
* idiopathic sensory neuropathy
* traumatic peripheral neuropathy
* central neuropathic pain condition (spinal cord injury, post-stroke pain), OR
* other peripheral neuropathy (upon mutual agreement of the sponsor and investigator).
Exclusion Criteria:
* Have a positive pregnancy test (females only)
* Have a history of or active asthma or emphysema
* Have clinically significant hepatic impairment
* Have a history of alcohol or substance abuse within the last 3 years
* Have a history of opioid abuse within 6 months prior to study entry
* Have a known allergy or significant reaction to opioids, including codeine
* Have a known oxymorphone sensitivity or allergy
* Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00911261
Study Brief:
Protocol Section:
NCT00911261