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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273454
• Other study ID #: CR016324
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2011
• Last updated: September 3, 2013
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 648
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• OROS Hydromorphone
8,16, 32 mg once a day for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change in sleep disturbance		between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))	No
Secondary	Breakthrough pain experience		between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))	No
Secondary	End-of-dose failure experience		between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))	No
Secondary	Patient satisfaction with study drug and detailed reason		at the last visit (DAY29 ± 7: from 22 day to 36 day))	No
Secondary	Investigator's global assessment		the last visit (DAY29 ± 7: from 22 day to 36 day)	No