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

NCT ID: NCT01273454

Last Updated: 2013-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 648 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Pain

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

001

OROS Hydromorphone 8 16 32 mg once a day for 4 weeks

OROS Hydromorphone

Intervention Type: DRUG

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

Interventions

OROS Hydromorphone

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd.

References

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.

Reference Type: DERIVED

PMID: 27822929 (View on PubMed)

Other Identifiers

CR016324

Identifier Type: -

Identifier Source: org_study_id