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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT01006356
Eligibility Criteria:
Inclusion Criteria:
* Cancer participants administering only strong oral opioid analgesic for cancer pain control
* Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)
* Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators
* Abstinent or surgically sterile female participants
Exclusion Criteria:
* Participants with cancer pain who are potentially unresponsive to narcotic analgesics
* Participants with presence or history of drug or alcohol abuse within the past 6 months
* Participants with hypersensitivity to hydromorphone HCl
* Participants with history of colectomy (surgery to remove part or all of the colon)
* Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01006356
Study Brief:
Protocol Section:
NCT01006356