Clinical trial NCT01621100: Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer Pain
Keywords: Cancer pain
OROS
Osmotic release oral system
Hydromorphone
Painkiller
Opioid analgesic
Korean patients
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-06-18
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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)
timeFrame: up to 17 days
Secondary outcomes:
measure: Korean Brief Pain Inventory (K-BPI) scores
timeFrame: up to 17 days
measure: European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores
timeFrame: up to 17 days
measure: Patient's Global Assessment (PGA) scores
timeFrame: up to 17 days
measure: Investigator's Global Assessment scores
timeFrame: up to 17 days
Other outcomes:
Locations:
city: Cheonan City
country: Korea, Republic of
city: Cheonan
country: Korea, Republic of
city: Cheongju
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Hwasun Gun
country: Korea, Republic of
city: Jeonju-Si
country: Korea, Republic of
city: Jinju-Si
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd
name: Janssen Korea, Ltd Clinical Trial
role: STUDY_DIRECTOR
References: