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

NCT ID: NCT01621100

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Cancer Pain

Keywords

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Cancer pain OROS Osmotic release oral system Hydromorphone Painkiller Opioid analgesic Korean patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OROS hydromorphone

Once-Daily OROS (Osmotic release oral system \[a controlled release oral drug delivery system in the form of a tablet\]) hydromorphone

Group Type EXPERIMENTAL

OROS hydromorphone

Intervention Type DRUG

Type= exact number, unit= mg, number= 4, form= tablet, route= oral, administered from 1st evaluation day (Day 1) to 2nd evaluation day (Day 15±2). Dosage adjustment: If NRS (Numeric Rating Scale) =4 or more then dose can be increased by 4mg until the average pain intensity for the past 24 hours is adjusted to lower than NRS 3. For the treatment of breakthrough pain, if necessary the one-time administration dose of quick-effect OROS Hydromorphone shall be 2mg up to the daily dosage of the study medicine, 12mg.

Interventions

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OROS hydromorphone

Type= exact number, unit= mg, number= 4, form= tablet, route= oral, administered from 1st evaluation day (Day 1) to 2nd evaluation day (Day 15±2). Dosage adjustment: If NRS (Numeric Rating Scale) =4 or more then dose can be increased by 4mg until the average pain intensity for the past 24 hours is adjusted to lower than NRS 3. For the treatment of breakthrough pain, if necessary the one-time administration dose of quick-effect OROS Hydromorphone shall be 2mg up to the daily dosage of the study medicine, 12mg.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd

Locations

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Cheonan, , South Korea

Site Status

Cheongju-si, , South Korea

Site Status

Daejeon, , South Korea

Site Status

Hwasun Gun, , South Korea

Site Status

Jeonju, , South Korea

Site Status

Jinju, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3208&filename=CR100659_CSR.pdf

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

Other Identifiers

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HYD-KOR-4003

Identifier Type: OTHER

Identifier Source: secondary_id

42801PAI4012

Identifier Type: OTHER

Identifier Source: secondary_id

CR100659

Identifier Type: -

Identifier Source: org_study_id