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
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Pain
Intervention: Hydromorphone HCl OROS (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s): Janssen Korea, Ltd., Korea Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd., Korea
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.
Clinical Details
Official title: Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
Secondary outcome: Frequency of Experiencing Breakthrough PainChange From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15 Pain Intensity Score Global Assessment of Overall Efficacy of Study Drug by Investigator Global Assessment of Overall Efficacy of Study Drug by Participant Participant's Preferences Along With Reasons Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Detailed description:
This is an open-label (all people know the identity of the intervention), multi-center
(conducted in more than 1 center), prospective (study following participants forward in
time) study. The total duration of study will be 3 weeks. The study consists of 2 periods
and 4 visits: screening period (1 week; Visit 1) and treatment period (2 weeks; Visit 2, 3
and 4). During screening period at Visit 1, potential participants will receive previously
administered oral opioid analgesic until the second visit and with immediate-release opioid
analgesic whenever breakthrough pain is present. During treatment period, from second visit
to the fourth visit, participants will receive the hydromorphone HCl OROS once daily for 2
weeks. At Investigator's discretion, participants completing 2 weeks of treatment with study
drug could be enrolled into the extension phase of 12-weeks. The dose of study drug is
flexible and will be increased or decreased based on the frequency of immediate-release
opioid analgesic doses needed to manage pain. At second visit, initial dose of hydromorphone
will be determined according to the equivalent analgesic effect conversion tablet (oxycodone
10 milligram [mg] twice daily is equal to hydromorphone HCl 8 mg once daily). The
Investigator will increase a participant's daily dose if more than 3 breakthrough pain
episodes require rescue medication within a 24 hours period. Participants' safety will be
monitored throughout the study.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2008
Last updated: July 9, 2013
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