An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Analgesics; Hydromorphone

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