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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Pain

Treatments: Drug: OROS Hydromorphone

Study type: Observational

Funder types: Industry

Identifiers

NCT01273454

CR016324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 648 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

648 participants in 1 patient group

001

Description:

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

Treatment:

Drug: OROS Hydromorphone