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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006356
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Pain Drug: Hydromorphone HCl OROS Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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'.

  5. 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'.

  6. 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.

  7. 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.

  8. 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.

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006356

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

Responsible Party: Janssen Korea, Ltd., Korea Identifier: NCT01006356     History of Changes
Other Study ID Numbers: CR015694
First Posted: November 2, 2009    Key Record Dates
Results First Posted: August 8, 2013
Last Update Posted: August 8, 2013
Last Verified: July 2013

Keywords provided by Janssen Korea, Ltd., Korea:
Hydromorphone hydrochloride Oral Osmotic System

Additional relevant MeSH terms:
Breakthrough Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents