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

Study Overview
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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.

Official Title
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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

Conditions
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Cancer, Pain

Intervention / Treatment
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* Drug: Hydromorphone HCl OROS


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)<br>Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks. | Drug: Hydromorphone HCl OROS<br>* Hydromorphone HCl OROS 8 mg once daily for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Experiencing Breakthrough Pain | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydromorphone hydrochloride Oral Osmotic System, Jurnista