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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT00411268
Eligibility Criteria:
Inclusion Criteria:
* Patients who have chronic low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release
* Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain
* Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release
Exclusion Criteria:
* Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
* Patients who are pregnant or breast-feeding
* Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
* Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
* Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00411268
Study Brief:
Protocol Section:
NCT00411268