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

Primary Purpose

Cancer Pain

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OROS hydromorphone
Sponsored by
Janssen Korea, Ltd., Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain focused on measuring Cancer pain, OROS, Osmotic release oral system, Hydromorphone, Painkiller, Opioid analgesic, Korean patients

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OROS hydromorphone

Arm Description

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

Outcomes

Primary Outcome Measures

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)
Average pain intensity is calculated (on 1st and 2nd evaluation days) for the past 24 hours of the patient using the NRS (Numeric Rating Scale) (0 = No pain, 10 = Unimaginably acute pain). PID (pain intensity difference) %= [NRS (1st evaluation day) - NRS (2nd evaluation day)]/ NRS (1st evaluation day).

Secondary Outcome Measures

Korean Brief Pain Inventory (K-BPI) scores
A survey (questionnaire) to measures the pain intensity, the effect of pain on the performance of everyday life, effect of medicines for pain treatment and degree of pain reduction.
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores
Quality of life measurement survey with 30 questions that ask about the health status of cancer patients.
Patient's Global Assessment (PGA) scores
Patient checks any of the 5 stages: 1 = Not effective, 2 = Normal, 3 = Effective, 4 = Very Effective, 5 = Excellently effective based on how effective the study medication is in their treatment of pain after the last evaluation.
Investigator's Global Assessment scores
Study investigator checks any of the 5 stages: 1 = Not effective, 2 = Normal, 3 = Effective, 4 = Very Effective, 5 = Excellently effective based on how effective the study medication is in their treatment of pain after the last evaluation.

Full Information

First Posted
April 10, 2012
Last Updated
September 5, 2013
Sponsor
Janssen Korea, Ltd., Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01621100
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Korea, Ltd., Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
Cancer pain, OROS, Osmotic release oral system, Hydromorphone, Painkiller, Opioid analgesic, Korean patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OROS hydromorphone
Arm Type
Experimental
Arm Description
Once-Daily OROS (Osmotic release oral system [a controlled release oral drug delivery system in the form of a tablet]) hydromorphone
Intervention Type
Drug
Intervention Name(s)
OROS hydromorphone
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
Average pain intensity is calculated (on 1st and 2nd evaluation days) for the past 24 hours of the patient using the NRS (Numeric Rating Scale) (0 = No pain, 10 = Unimaginably acute pain). PID (pain intensity difference) %= [NRS (1st evaluation day) - NRS (2nd evaluation day)]/ NRS (1st evaluation day).
Time Frame
up to 17 days
Secondary Outcome Measure Information:
Title
Korean Brief Pain Inventory (K-BPI) scores
Description
A survey (questionnaire) to measures the pain intensity, the effect of pain on the performance of everyday life, effect of medicines for pain treatment and degree of pain reduction.
Time Frame
up to 17 days
Title
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores
Description
Quality of life measurement survey with 30 questions that ask about the health status of cancer patients.
Time Frame
up to 17 days
Title
Patient's Global Assessment (PGA) scores
Description
Patient checks any of the 5 stages: 1 = Not effective, 2 = Normal, 3 = Effective, 4 = Very Effective, 5 = Excellently effective based on how effective the study medication is in their treatment of pain after the last evaluation.
Time Frame
up to 17 days
Title
Investigator's Global Assessment scores
Description
Study investigator checks any of the 5 stages: 1 = Not effective, 2 = Normal, 3 = Effective, 4 = Very Effective, 5 = Excellently effective based on how effective the study medication is in their treatment of pain after the last evaluation.
Time Frame
up to 17 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Korea, Ltd Clinical Trial
Organizational Affiliation
Janssen Korea, Ltd
Official's Role
Study Director
Facility Information:
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

12. IPD Sharing Statement

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

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

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