CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 190 enrolled
Drug / intervention
Hydromorphonedrug
Likely dose
Hydromorphone 8 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00766831
NCT00766831Phase 4Completed
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Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance

Janssen Korea, Ltd., Korea·interventional·Posted Oct 6, 2008·Updated Oct 23, 2013

In Brief

A Phase 4 clinical trial evaluating Hydromorphone for Cancer Pain. Completed, enrolled 190 participants.

Detailed Summary

The purpose of this is study to evaluate improvement of sleep disorder caused by cancer pain after the administration of Hydromorphone Oral Osmotic System (OROS) in Korean participants with cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer Pain
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2008
Enrollment StartOct 1, 2008
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.7 years ago

Interventions

Hydromorphonedrug

Participants will receive hydromorphone OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.