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

July 9, 2013 updated by: Janssen Korea, Ltd., Korea

Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)
Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks.
Drug: Hydromorphone HCl OROS
Hydromorphone HCl OROS 8 mg once daily for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
Time Frame: Day 15
Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).
Day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Experiencing Breakthrough Pain
Time Frame: Day 1 and Day 15
Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.
Day 1 and Day 15
Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15
Time Frame: Baseline and Day 15
K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.
Baseline and Day 15
Pain Intensity Score
Time Frame: Day 3 and Day 13
Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.
Day 3 and Day 13
Global Assessment of Overall Efficacy of Study Drug by Investigator
Time Frame: Day 15
Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.
Day 15
Global Assessment of Overall Efficacy of Study Drug by Participant
Time Frame: Day 15
Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.
Day 15
Participant's Preferences Along With Reasons
Time Frame: Day 15
The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.
Day 15
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Time Frame: Day 15
Investigators evaluated the overall improvement of the participant's condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.
Day 15
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Time Frame: Day 1 and Day 15
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.
Day 1 and Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR015694
  • 42801PAI4006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Hydromorphone HCl OROS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings