Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Breakthrough Pain

Neurologic Manifestations

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Hydromorphone

Analgesics, Opioid

Narcotics

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

Hydromorphone HCl OROS 8 mg once daily for 2 weeks.

Hydromorphone HCl OROS

Janssen Korea, Ltd., Korea Clinical Trial

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.

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.

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

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

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).

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.

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.

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.

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'.

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'.

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.

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.

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.

Janssen Korea, Ltd., Korea

Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.

Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.

Age Continuous was measured for intent-to-treat (ITT) analysis population which was defined as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Visit 3 (Day 8).

Age Continuous

Gender was measured for ITT analysis population which was defined as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Visit 3 (Day 8).

Sex: Female, Male

Baseline characteristics was measured for intent-to-treat (ITT) analysis population which was defined as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Visit 3 (Day 8).

Medical Director

The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. Last observation carried forward (LOCF) was used.

Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain

Day 1: Incidental Pain

Day 15: Incidental Pain

Day 1: Idiopathic Pain

Day 15: Idiopathic Pain

Day 1: End-of-dose failure

Day 15: End-of-dose failure

The ITT analysis population included all the as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.

Frequency of Experiencing Breakthrough Pain

Baseline

Change at Day 15

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.

Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15

Day 3 (8 AM) (n=106)

Day 3 (8 PM) (n=106)

Day 13 (8 AM) (n=103)

Day 13 (8 PM) (n=103)

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.

Pain Intensity Score

Ineffective response

Average response

Effective response

Very effective response

Highly effective response

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here "N" signifies participants evaluated for this outcome measure.

Global Assessment of Overall Efficacy of Study Drug by Investigator

Ineffective

Average

Effective

Very effective

Highly effective

Global Assessment of Overall Efficacy of Study Drug by Participant

Hydromorphone OROS:Consistent effect(n=91)

Oral Opioid: Consistent effect(n=9)

Hydromorphone OROS: Sleep undisturbed(n=91)

Hydromorphone OROS:reduced intake frequency(n=91)

Hydromorphone OROS:reduced intake(n=91)

Hydromorphone OROS:Other(n=91)

Oral Opioid: Other(n=9)

Oral Opioid: No response(n=9)

The ITT analysis population included all participants who received at least 1 dose of study drug and had available data in dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure and 'n'=participants who took hydromorphone OROS/oral opioid.

Participant's Preferences Along With Reasons

greatly improved

somewhat improved

slightly improved

no change

slightly aggravated

somewhat aggravated

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure.

Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score

Day 1: Trouble in strenuous activities (n=106)

Day 15: Trouble in strenuous activities (n=106)

Day 1: Trouble in long walk (n=106)

Day 15: Trouble in long walk (n=106)

Day 1: Trouble in short walk outside house (n=106)

Day 15: Trouble in short walk outside house(n=106)

Day 1: Stay in bed/chair (n=106)

Day 15: Stay in bed/chair (n=106)

Day 1: Need help in usual activities (n=106)

Day 15: Need help in usual activities (n=106)

Day 1: Limitation in work/other activites (n=106)

Day 15: Limitation in work/other activites (n=106)

Day 1:Limitation-hobbies/leisure activites(n=106)

Day 15:Limitation-hobbies/leisure activites(n=106)

Day 1: Short of breath (n=106)

Day 15: Short of breath (n=106)

Day 1: Had pain (n=106)

Day 15: Had pain (n=106)

Day 1: Needs rest (n=105)

Day 15: Needs rest (n=105)

Day 1: Trouble in sleeping (n=106)

Day 15: Trouble in sleeping (n=106)

Day 1: Felt weak (n=106)

Day 15: Felt weak (n=106)

Day 1: Apetite loss (n=106)

Day 15: Apetite loss (n=106)

Day 1: Felt nauseated (n=106)

Day 15: Felt nauseated (n=106)

Day 1: Vomitting (n=106)

Day 15: Vomitting (n=106)

Day 1: Constipation (n=106)

Day 15: Constipation (n=106)

Day 1: Diarrhea (n=106)

Day 15: Diarrhea (n=106)

Day 1: Tired (n=106)

Day 15: Tired (n=106)

Day 1:Pain interference - daily activities(n=106)

Day 15:Pain interference - daily activities(n=106)

Day 1: Difficulty in concentrating (n=106)

Day 15: Difficulty in concentrating (n=106)

Day 1: Felt tensed (n=106)

Day 15: Felt tensed (n=106)

Day 1: Worried (n=106)

Day 15: Worried (n=106)

Day 1: Felt irritated (n=106)

Day 15: Felt irritated (n=106)

Day 1: Felt depressed (n=106)

Day 15: Felt depressed (n=106)

Day 1: Difficulty in remembering (n=104)

Day 15: Difficulty in remembering (n=104)

Day 1: Interference in family life (n=106)

Day 15: Interference in family life (n=106)

Day 1: Interference in social life (n=106)

Day 15: Interference in social life (n=106)

Day 1: Economical difficulties (n=106)

Day 15: Economical difficulties (n=106)

Day 1: Global health status (n=106)

Day 15: Global health status (n=106)

Day 1: Quality of life (n=106)

Day 15: Quality of life (n=106)

European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score

Hydromorphone Hydrochloride Oral Osmotic System

Overall Study

Spots Global Cancer Trial Database for hydromorphone hcl oros