An Observational Study to Investigate Clinical Usefulness of OROS Hydromorphone in Korean Cancer Patients

An Open-label, Multi-center, Non-interventional Study to Investigate Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01273454

Enrollment

648

Registered

2011-01-10

Start date

2009-06-30

Completion date

2009-12-31

Last updated

2013-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Open-label, Non-interventional, OROS hydromorphone, Korean cancer patients

Brief summary

This study aims to collect clinical information and to examine the usefulness and safety of ORal Osmotic System Hydromorphone in Korean cancer patients. The decision to treat patients with drug is as per physician discretion and that doses are determined based upon approved labeling recommendations and physician discretion.

Detailed description

The primary purpose of this observational study is to collect clinical data on cancer pain control using OROS (ORal Osmotic Active System) hydromorphone and to investigate the clinical usefulness of OROS hydromorphone for Korean cancer patients. Information on the effectiveness of cancer pain control and any adverse events reported by those patients using OROS Hydromorphone will be reported. In addition, clinical usefulness of OROS hydromorphone will be evaluated through assessing sleep disturbance due to pain, breakthrough pain, and end-of-dose failure before and after the study drug administration and examining the patient's satisfaction with study drug and the investigator's global assessment. This is a multi-center, open-label, prospective, exploratory, and observational study with approximately 770 patients. Efficacy endpoints will be analyzed to examine the difference between before and after the treatment. Since this is an observational study under the condition of routine practice, OROS Hydromorphone dosage should be adjusted at the discretion of the investigator, based on patient response. It is recommended that the dosage be conservative at first and adjusted appropriately considering the adverse events and analgesic effect for all the patients.

Interventions

DRUGOROS Hydromorphone

8,16, 32 mg once a day for 4 weeks

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who are in need OROS hydromorphone to relieve cancer pain

Exclusion criteria

* Patients with serious gastrointestinal diseases that may interfere with oral analgesic effects, such as dysphagia, vomiting, absence of periastalsis, intestinal obstruction, and/or severe strangulation, in which case the absorption and passage of orally-administered medication may be unduly influenced

Design outcomes

Primary

Measure	Time frame
Change in pain intensity score (where 0 is worst and 10 is best) as measured on the Numeric Rating Scale (NRS) from baseline to Day 36	Between Visit 1 (day 1) and the last visit (day 29 ± 7: from day 22 to day 36)

Secondary

Measure	Time frame
Change in sleep disturbance	between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))
Breakthrough pain experience	between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))
End-of-dose failure experience	between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))
Patient satisfaction with study drug and detailed reason	at the last visit (DAY29 ± 7: from 22 day to 36 day))
Investigator's global assessment	the last visit (DAY29 ± 7: from 22 day to 36 day)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026