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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT00226395
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients 18 years of age or older
* Patients undergoing surgery through an abdominal incision of at least 3 cm who are expected to be hospitalized for at least 36 hours and are expected to subsequently require at least 48 hours of oral opioid therapy.
* Washout of at least 45 minutes for parenteral and 4 hours for IM analgesia.
* Initial pain intensity score of at least 50 mm on a 100-mm VAS and a categorical pain rating of moderate or severe on a scale of none, mild, moderate, or severe.
* Written informed consent.
Exclusion Criteria:
* Known allergy or significant reaction to opioids.
* History of chronic opioid use or opioid abuse within 6 months prior to study entry.
* History of alcohol or substance abuse within the last 3 years.
* Have been a participant in a study of an investigational drug or device within 30 days prior to study entry.
* Have been a previous participant in an oxymorphone clinical trial.
* Are currently taking or have taken a monoamine oxidase inhibitor (MAOI) drug within 2 weeks prior to study entry.
* Are currently taking or have taken St. John's Wort \>1000 mg/day within 2 days prior to study entry.
* Use of long-acting oral and parenteral analgesics (opioid, non-opioid or non-steroidal anti-inflammatory drug \[NSAID\]) within 12 hours (at least 24 hours for cyclooxygenase-2 \[COX 2\] analgesics) prior to receiving study medication.
* Are not stabilized on the following medications for at least 4 weeks prior to dosing: tricyclic antidepressant drugs; serotonin reuptake inhibitors; amphetamines used for attention-deficit hyperactivity disorder (ADHD)
* Have a history of seizure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00226395
Study Brief:
Protocol Section:
NCT00226395