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
|ClinicalTrials.gov Identifier: NCT01006356|
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain||Drug: Hydromorphone HCl OROS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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.
- 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.
- 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.
- 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'.
- 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'.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006356
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|