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:
NCT02662556
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients who are 40 years of age or older.
2. Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
3. Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I).
Exclusion Criteria:
1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
2. Patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication.
3. Patients with a history of opioid dependence within 2 years before the start of the study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified in Appendix II.
4. Patients who have used any illicit drugs of abuse within five years before the start of the study.
5. Patients who have abused any prescription medication or alcohol within one year before the start of the study.
6. Patients with an allergy or hypersensitivity to opioids.
7. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
8. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02662556
Study Brief:
Protocol Section:
NCT02662556