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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT02603705
Eligibility Criteria:
Inclusion Criteria:
* Is a man or woman between 18 and 75 years of age.
* Has a clinical history of moderate-to-severe chronic noncancer pain ≥6 months.
* Has required opioid therapy for at least 14 days prior to Screening at a dose between 20 mg and 160 mg (inclusive) oxycodone/day (or opioid equivalent), and will, in the opinion of the investigator, continue to require opioid therapy (between 20 mg and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe pain for the duration of the study.
* Has pain either not adequately controlled on current opioid regimen, requires a change of opioid due to tolerability of current opioid regimen or in the opinion of the investigator, would benefit from changing opioid for another reason.
* Has stable health, as determined by the investigator.
* If female, the patient is currently not pregnant, not breast-feeding, nor attempting to become pregnant (for 30 days before screening through the duration of the study), or is of non-childbearing potential.
* Other Criteria Apply
Exclusion Criteria:
* Has cancer-related pain.
* Is receiving \>240 mg oxycodone daily (or opioid equivalent) within 30 days before Screening.
* Has a history of attempted suicide.
* Has used a spinal infusion pump within 6 months before Screening.
* Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) and/or respiratory disease (including chronic obstructive pulmonary disease or sleep apnea).
* Has positive urine toxicity screen for drugs of abuse (with the exception of prescribed medications).
* Has positive result for tetrahydrocannabinol (even if legally prescribed).
* Has current (or history of within the last 12 months) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
* Other Criteria Apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02603705
Study Brief:
Protocol Section:
NCT02603705