Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
3 other identifiers
observational
400
1 country
11
Brief Summary
The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 18, 2014
March 1, 2014
1 year
February 10, 2012
March 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients
Baseline and at approximately Day 57
Secondary Outcomes (9)
Changes in the Karnofsky Performance Rating Scale (KPRS)
Baseline, and at approximately Days 29 and 57
Change in pain relief (%)
Baseline, and at approximately Days 29 and 57
Frequency of awakening
Baseline, and at approximately Days 29 and 57
Level of sleep inconvenience
Baseline, and at approximately Days 29 and 57
Satisfaction with sleep
Baseline, and at approximately Days 29 and 57
- +4 more secondary outcomes
Study Arms (1)
Hydromorphone HCI OROS
Interventions
type= exact number, unit= mg, number=4, form= tablet, route= oral use. One tablet administered once a day. The dose may be increased if the level of pain increases or if the pain-killing effect is insufficient.
Eligibility Criteria
Korean cancer patients having cancer pain who visit or are hospitalized at the research centers during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Ansan, South Korea
Unknown Facility
Busan, South Korea
Unknown Facility
Cheongju-si, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Hwasun Gun, South Korea
Unknown Facility
Incheon, South Korea
Unknown Facility
Pusan, South Korea
Unknown Facility
Seognam-Si, Kyungki-Do, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Suwon, South Korea
Unknown Facility
Wonju-Shi, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd., Korea Clinical Trial
Janssen Korea, Ltd., Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2012
First Posted
February 15, 2012
Study Start
September 1, 2011
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
March 18, 2014
Record last verified: 2014-03