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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT00411034
Eligibility Criteria:
Inclusion Criteria:
* Patients who have chronic cancer pain who are currently receiving strong oral or transdermal opioid analgesics or patients suitable for advancement of therapy to step 3 on the WHO (World Health Organization) analgesic ladder
* patients who can reasonably be expected to have stable opioid requirements for the duration of the study
Exclusion Criteria:
* Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
* patients who are pregnant or breast-feeding
* patients with severe respiratory compromise or severely depressed ventilatory function
* patients with any gastrointestinal disorder or acute abdominal conditions including pre-existing severe GI narrowing (pathologic or iatrogenic), that may affect the absorption or transit of orally administered drugs
* patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, dysphagia or are unable to swallow tablets or any significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00411034
Study Brief:
Protocol Section:
NCT00411034