Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid

Pain Clinical Trial

Official title:

Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532895
• Other study ID #: CR100741
• Secondary ID: 42801PAI4013HYD-
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2012
• Last updated: March 15, 2014
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardRepublic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.

Description:

This is a multicenter, prospective, open-label (all people know the identity of the intervention) and observational study. Patients selected for the proposed study are patients complaining of cancer pain who visit or are hospitalized at the research centers during the study, who are not being treated with strong continuous opioid (narcotic medication used against the pain), and who require cancer pain control with hydromorphone, at the investigator's discretion. The study will evaluate the changes in pain relief, level of sleep deprivation, and the patients' quality of life before and after administration of hydromorphone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria: - Patients who complain of cancer pain and who require administration of hydromorphone HCl - Patients who can follow the requirements of the overall study, including completion of filling out the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, at the investigator's discretion - Signed informed consent Exclusion Criteria: - Patients who received strong continuous narcotic analgesics (eg morphine, fentanyl, oxycodone, hydromorphone) within 4 weeks prior to administration of the study drug - Patients who have a medical history of receiving drugs in the past or currently, or of drug abuse - Patients who did not agree to conduct the approved methods for contraception during the study - Patients who have sustained injuries in physical functions or diseases which may cause abnormalities in absorbing the study drug, excessive accumulation and metabolic or elimination disorder - Patients who are receiving Monoamine Oxidase Inhibitors (MAO) inhibitors or who are within 2 weeks from discontinuation - Patients who need to be excluded based on precautions in the user manual of the study drug, notice and contradictions, at the investigator's discretion

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Hydromorphone HCI OROS
type= exact number, unit= mg, number=4, form= tablet, route= oral use. One tablet administered once a day. The dose may be increased if the level of pain increases or if the pain-killing effect is insufficient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients		Baseline and at approximately Day 57	No
Secondary	Changes in the Karnofsky Performance Rating Scale (KPRS)	The KPRS measures the physical functions of cancer patients, and indicates the feasibility of daily life by 10% units from 0% (death) to 100% (normal status in which patients can do activities to the level before disease without limitations).	Baseline, and at approximately Days 29 and 57	No
Secondary	Change in pain relief (%)	How much pain was relieved by the pain therapy or medication for the last 24 hours, using %: 0%= nothing reduced and 100%= completely reduced.	Baseline, and at approximately Days 29 and 57	No
Secondary	Frequency of awakening	Check whether patients experienced awakening during sleep caused by pain for the last 1 week or not, and measure the frequency (1 = once, 2 = twice, 3 = 3 times, 4 = more than 4 times, 5 = not woken, 6 = never slept).	Baseline, and at approximately Days 29 and 57	No
Secondary	Level of sleep inconvenience	Measure the level of sleep inconvenience that patients experienced due to pain for the last 1 week using the Numeric Rating Scale (NRS); 0 = not causing inconvenience, 10 = completely causing inconvenience.	Baseline, and at approximately Days 29 and 57	No
Secondary	Satisfaction with sleep	Indicate the overall satisfaction with sleep by improving sleep disturbance caused by pain for the last 1 week using the Numeric Rating Scale (0 "never satisfied" on the left end; 10 "very satisfied" on the right end).	Baseline, and at approximately Days 29 and 57	No
Secondary	Quality of life assessment measured by the EORTC QLQ-C15 PAL	The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15 (Quality of Life Questionnaire Core 15) is a commonly used questionnaire to assess the quality of life of cancer patients taking paliative medicine. This questionnaire consists of questions measuring physical, role, emotional, cognitive and social functions, and answers are given based on a 4-point scale, from 1 (not at all) to 4 (very much so).	Baseline, and at approximately Days 29 and 57	No
Secondary	Investigator's Global Assessment	The investigator's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the investigator from the investigator's point of view as 1 = not effective, 2 = normal l, 3 = effective, 4 very effective, and 5 = extremely effective.	At approximately Days 29 and 57	No
Secondary	Patient's Global Assessment	The patient's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the patient from the patient's point of view as 1 = not effective, 2 = normal, 3 = effective, 4 = very effective, and 5 = extremely effective.	At approximately Days 29 and 57	No
Secondary	CGI-I (Clinical Global Impression - Improvement)	Evaluate how much patients have improved compared with the conditions of patients at baseline, from 1 (very much improved) to 7 (greatly deteriorated).	At approximately Days 29 and 57	No