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

NCT01273454 | Completed

• 1 other identifier: CR016324
• Study Type: observational
• Target: 648
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Open-label; Non-interventional; OROS hydromorphone; Korean cancer patients

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Change in sleep disturbance

  between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))

• Breakthrough pain experience

  between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))

• End-of-dose failure experience

  between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))

• Patient satisfaction with study drug and detailed reason

  at the last visit (DAY29 ± 7: from 22 day to 36 day))

• Investigator's global assessment

  the last visit (DAY29 ± 7: from 22 day to 36 day)

Study Arms (1)

001

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

Drug: OROS Hydromorphone

Interventions

OROS Hydromorphone DRUG

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

001

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who are in need OROS hydromorphone to relieve cancer pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Related Publications (1)

• 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.

  PMID: 27822929 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 4, 2013

Record last verified: 2013-09