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Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients

Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer Pain

Intervention: OROS hydromorphone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Korea, Ltd., Korea

Official(s) and/or principal investigator(s):
Janssen Korea, Ltd Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd

Summary

The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily OROS ("Osmotic Release Oral System" [a controlled release oral medication delivery system in the form of a tablet]) hydromorphone for cancer pain treatment in Korean cancer patients.

Clinical Details

Official title: A Prospective, Open-Label, Multicenter, Single-Arm, Interventional Study to Evaluate the Efficacy and Tolerability of Once-Daily Oros Hydromorphone for Cancer Pain Treatment in Korean Cancer Patients.

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of patients with 50% or more average Pain Intensity Difference (PID) from 1st evaluation day (Day 1) to the 2nd evaluation day (Days 15±2)

Secondary outcome:

Korean Brief Pain Inventory (K-BPI) scores

European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores

Patient's Global Assessment (PGA) scores

Investigator's Global Assessment scores

Detailed description: This is a prospective (expected to happen), open-label (type of clinical study in which both the researchers and participants know which treatment is being administered), multicenter (conducted at multiple centers), single-arm (only one group), study to evaluate the effectiveness and tolerability (capable to tolerate) of Once-Daily OROS hydromorphone for cancer pain treatment. This is a 14-week study consisting of 2-week efficacy evaluation period (1st evaluation on Day 1 and 2nd evaluation on Days 15±2) and a 12-week extension phase. 99 patients will receive Once-Daily OROS hydromorphone for 2 weeks .After 2 weeks, if a patient has continuous cancer pain and the investigator deems it necessary to administer the same medicine as the study medication then the patient may participate voluntarily in the 12 weeks extension phase. At the extension phase, other continuous-type strong opioid analgesics (painkiller) may be administered at the same time for the adjustment of cancer pain based on the discretion of the investigator.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Cancer pain and require opioid analgesics

- Average pain intensity measured at the baseline (patient's medical status before any

treatment or research is done) for the past 24 hours over Numeric Rating Scale (NRS) is 4

- Never taken continuous-type strong opioid analgesics

- Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth

control Exclusion Criteria:

- Acute digestion related disease, such as dysphagia (difficulty in swallowing),

vomiting, no enterokinesia (movements of intestine), intestinal obstruction, acute intestinal stricture (narrowing of a passageway)

- Expected to undergo radioactive treatment (radiation therapy) between Day 1 and Day

15 of study

- Being administered with monoamine oxidase inhibitor (eg, moclobemide, selegiline,

toloxatone, etc) or within 2 weeks of administration thereof

Locations and Contacts

Cheonan City, Korea, Republic of

Cheonan, Korea, Republic of

Cheongju, Korea, Republic of

Daejeon, Korea, Republic of

Hwasun Gun, Korea, Republic of

Jeonju-Si, Korea, Republic of

Jinju-Si, Korea, Republic of

Additional Information

A Prospective, Open-Label, Multicenter, Single-Arm, Interventional Study to Evaluate the Efficacy and Tolerability of Once-Daily Oros Hydromorphone for Cancer Pain Treatment in Korean Cancer Patients

Starting date: December 2011
Last updated: September 5, 2013

Page last updated: August 23, 2015

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