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

January 7, 2011
September 3, 2013
June 2009
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01273454 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Pain
Drug: OROS Hydromorphone
8,16, 32 mg once a day for 4 weeks
001
OROS Hydromorphone 8 16 32 mg once a day for 4 weeks
Intervention: Drug: OROS Hydromorphone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
648
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01273454
CR016324
Not Provided
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
Janssen Korea, Ltd., Korea
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP