Clinical trial NCT01006356: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Pain
Keywords: Hydromorphone hydrochloride Oral Osmotic System
Jurnista
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 141
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
timeFrame: Day 15
Secondary outcomes:
measure: Frequency of Experiencing Breakthrough Pain
timeFrame: Day 1 and Day 15
measure: Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15
timeFrame: Baseline and Day 15
measure: Pain Intensity Score
timeFrame: Day 3 and Day 13
measure: Global Assessment of Overall Efficacy of Study Drug by Investigator
timeFrame: Day 15
measure: Global Assessment of Overall Efficacy of Study Drug by Participant
timeFrame: Day 15
measure: Participant's Preferences Along With Reasons
timeFrame: Day 15
measure: Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: Day 15
measure: European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
timeFrame: Day 1 and Day 15
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: