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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: OROS Hydromorphone

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.

• Study Type: Observational
• Enrollment (Actual): 648

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from cancer pain who visit the study sites during study and eligible to be treated with OROS hydromorphone at the discretion of the investigator.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
001; OROS Hydromorphone 8 16 32 mg once a day for 4 weeks	Drug: OROS Hydromorphone; 8,16, 32 mg once a day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Publications and helpful links

General Publications

• Park CK, Kang HW, Oh IJ, Kim YC, Kim YK, Na KJ, Ahn SJ, Kim TO, Choi YJ, Song GA, Lee MK. Once-Daily OROS Hydromorphone for Management of Cancer Pain: an Open-Label, Multi-Center, Non-Interventional Study. J Korean Med Sci. 2016 Dec;31(12):1914-1921. doi: 10.3346/jkms.2016.31.12.1914.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (ESTIMATE): January 10, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 4, 2013
• Last Update Submitted That Met QC Criteria: September 3, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Open-label; Non-interventional; OROS hydromorphone; Korean cancer patients
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Hydromorphone
• Other Study ID Numbers: CR016324