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An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer

NCT ID: NCT01006356

Last Updated: 2013-08-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.

Detailed Description

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This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) study. The total duration of study will be 3 weeks. The study consists of 2 periods and 4 visits: screening period (1 week; Visit 1) and treatment period (2 weeks; Visit 2, 3 and 4). During screening period at Visit 1, potential participants will receive previously administered oral opioid analgesic until the second visit and with immediate-release opioid analgesic whenever breakthrough pain is present. During treatment period, from second visit to the fourth visit, participants will receive the hydromorphone HCl OROS once daily for 2 weeks. At Investigator's discretion, participants completing 2 weeks of treatment with study drug could be enrolled into the extension phase of 12-weeks. The dose of study drug is flexible and will be increased or decreased based on the frequency of immediate-release opioid analgesic doses needed to manage pain. At second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion tablet (oxycodone 10 milligram \[mg\] twice daily is equal to hydromorphone HCl 8 mg once daily). The Investigator will increase a participant's daily dose if more than 3 breakthrough pain episodes require rescue medication within a 24 hours period. Participants' safety will be monitored throughout the study.

Conditions

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Cancer Pain

Keywords

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Hydromorphone hydrochloride Oral Osmotic System Jurnista

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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Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)

Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks.

Group Type EXPERIMENTAL

Hydromorphone HCl OROS

Intervention Type DRUG

Hydromorphone HCl OROS 8 mg once daily for 2 weeks.

Interventions

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Hydromorphone HCl OROS

Hydromorphone HCl OROS 8 mg once daily for 2 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Cancer participants administering only strong oral opioid analgesic for cancer pain control
* Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)
* Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators
* Abstinent or surgically sterile female participants

Exclusion Criteria

* Participants with cancer pain who are potentially unresponsive to narcotic analgesics
* Participants with presence or history of drug or alcohol abuse within the past 6 months
* Participants with hypersensitivity to hydromorphone HCl
* Participants with history of colectomy (surgery to remove part or all of the colon)
* Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication
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., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Other Identifiers

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42801PAI4006

Identifier Type: -

Identifier Source: secondary_id

CR015694

Identifier Type: -

Identifier Source: org_study_id