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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01273454
First received: January 7, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Pain
Drug: OROS Hydromorphone
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Open-label, Multi-center, Non-interventional Study to Investigate Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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 [ Time Frame: Between Visit 1 (day 1) and the last visit (day 29 ± 7: from day 22 to day 36) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in sleep disturbance [ Time Frame: between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day)) ] [ Designated as safety issue: No ]
  • Breakthrough pain experience [ Time Frame: between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day)) ] [ Designated as safety issue: No ]
  • End-of-dose failure experience [ Time Frame: between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day)) ] [ Designated as safety issue: No ]
  • Patient satisfaction with study drug and detailed reason [ Time Frame: at the last visit (DAY29 ± 7: from 22 day to 36 day)) ] [ Designated as safety issue: No ]
  • Investigator's global assessment [ Time Frame: the last visit (DAY29 ± 7: from 22 day to 36 day) ] [ Designated as safety issue: No ]

Enrollment: 648
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273454

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01273454     History of Changes
Other Study ID Numbers: CR016324
Study First Received: January 7, 2011
Last Updated: September 3, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Open-label
Non-interventional
OROS hydromorphone
Korean cancer patients

Additional relevant MeSH terms:
Hydromorphone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014