Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01006356
Status:
COMPLETED
Last Update Posted:
2013-08-08
First Post:
2009-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+82-2-2094-4518', 'title': 'Medical Director', 'organization': 'Medical department / Korea'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Day 15', 'description': 'Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.', 'otherNumAtRisk': 107, 'otherNumAffected': 95, 'seriousNumAtRisk': 107, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 61, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 28, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 53, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 45, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastases tobone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsil cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mallory-weisssyndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Comahepatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': '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).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Frequency of Experiencing Breakthrough Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'title': 'Day 1: Incidental Pain', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Incidental Pain', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Idiopathic Pain', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Idiopathic Pain', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: End-of-dose failure', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: End-of-dose failure', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 15', 'description': '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.', 'unitOfMeasure': 'Pain episodes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.66', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 15', 'categories': [{'measurements': [{'value': '0.359', 'spread': '1.191', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 15', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'title': 'Day 3 (8 AM) (n=106)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 3 (8 PM) (n=106)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 13 (8 AM) (n=103)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 13 (8 PM) (n=103)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 and Day 13', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Global Assessment of Overall Efficacy of Study Drug by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'title': 'Ineffective response', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Average response', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Effective response', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Very effective response', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Highly effective response', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': "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'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Overall Efficacy of Study Drug by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'title': 'Ineffective', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Average', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Effective', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Very effective', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Highly effective', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': "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'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': "Participant's Preferences Along With Reasons", 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'title': 'Hydromorphone OROS:Consistent effect(n=91)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Oral Opioid: Consistent effect(n=9)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hydromorphone OROS: Sleep undisturbed(n=91)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hydromorphone OROS:reduced intake frequency(n=91)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Hydromorphone OROS:reduced intake(n=91)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Hydromorphone OROS:Other(n=91)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Oral Opioid: Other(n=9)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Oral Opioid: No response(n=9)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'title': 'greatly improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'somewhat improved', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'slightly improved', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'no change', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'slightly aggravated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'somewhat aggravated', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': "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.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'classes': [{'title': 'Day 1: Trouble in strenuous activities (n=106)', 'categories': [{'measurements': [{'value': '3.00', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Trouble in strenuous activities (n=106)', 'categories': [{'measurements': [{'value': '3.07', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Trouble in long walk (n=106)', 'categories': [{'measurements': [{'value': '2.98', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Trouble in long walk (n=106)', 'categories': [{'measurements': [{'value': '3.18', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Trouble in short walk outside house (n=106)', 'categories': [{'measurements': [{'value': '1.98', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Trouble in short walk outside house(n=106)', 'categories': [{'measurements': [{'value': '2.22', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Stay in bed/chair (n=106)', 'categories': [{'measurements': [{'value': '2.64', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Stay in bed/chair (n=106)', 'categories': [{'measurements': [{'value': '2.71', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Need help in usual activities (n=106)', 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Need help in usual activities (n=106)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Limitation in work/other activites (n=106)', 'categories': [{'measurements': [{'value': '2.58', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Limitation in work/other activites (n=106)', 'categories': [{'measurements': [{'value': '2.66', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Day 1:Limitation-hobbies/leisure activites(n=106)', 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Day 15:Limitation-hobbies/leisure activites(n=106)', 'categories': [{'measurements': [{'value': '2.61', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Short of breath (n=106)', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Short of breath (n=106)', 'categories': [{'measurements': [{'value': '2.04', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Had pain (n=106)', 'categories': [{'measurements': [{'value': '2.90', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Had pain (n=106)', 'categories': [{'measurements': [{'value': '2.66', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Needs rest (n=105)', 'categories': [{'measurements': [{'value': '2.74', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Needs rest (n=105)', 'categories': [{'measurements': [{'value': '2.78', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Trouble in sleeping (n=106)', 'categories': [{'measurements': [{'value': '2.18', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Trouble in sleeping (n=106)', 'categories': [{'measurements': [{'value': '2.13', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Felt weak (n=106)', 'categories': [{'measurements': [{'value': '2.50', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Felt weak (n=106)', 'categories': [{'measurements': [{'value': '2.52', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Apetite loss (n=106)', 'categories': [{'measurements': [{'value': '2.27', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Apetite loss (n=106)', 'categories': [{'measurements': [{'value': '2.41', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Felt nauseated (n=106)', 'categories': [{'measurements': [{'value': '1.75', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Felt nauseated (n=106)', 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Vomitting (n=106)', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Vomitting (n=106)', 'categories': [{'measurements': [{'value': '1.24', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Constipation (n=106)', 'categories': [{'measurements': [{'value': '2.15', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Constipation (n=106)', 'categories': [{'measurements': [{'value': '2.08', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Diarrhea (n=106)', 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.65', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Diarrhea (n=106)', 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.47', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Tired (n=106)', 'categories': [{'measurements': [{'value': '2.62', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Tired (n=106)', 'categories': [{'measurements': [{'value': '2.51', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Day 1:Pain interference - daily activities(n=106)', 'categories': [{'measurements': [{'value': '2.69', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Day 15:Pain interference - daily activities(n=106)', 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Difficulty in concentrating (n=106)', 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Difficulty in concentrating (n=106)', 'categories': [{'measurements': [{'value': '2.13', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Felt tensed (n=106)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Felt tensed (n=106)', 'categories': [{'measurements': [{'value': '2.01', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Worried (n=106)', 'categories': [{'measurements': [{'value': '2.12', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Worried (n=106)', 'categories': [{'measurements': [{'value': '2.16', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Felt irritated (n=106)', 'categories': [{'measurements': [{'value': '2.22', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Felt irritated (n=106)', 'categories': [{'measurements': [{'value': '2.20', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Felt depressed (n=106)', 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Felt depressed (n=106)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Difficulty in remembering (n=104)', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Difficulty in remembering (n=104)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Interference in family life (n=106)', 'categories': [{'measurements': [{'value': '2.47', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Interference in family life (n=106)', 'categories': [{'measurements': [{'value': '2.59', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Interference in social life (n=106)', 'categories': [{'measurements': [{'value': '2.58', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Interference in social life (n=106)', 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Economical difficulties (n=106)', 'categories': [{'measurements': [{'value': '2.58', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Economical difficulties (n=106)', 'categories': [{'measurements': [{'value': '2.51', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Global health status (n=106)', 'categories': [{'measurements': [{'value': '3.42', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Global health status (n=106)', 'categories': [{'measurements': [{'value': '3.42', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Quality of life (n=106)', 'categories': [{'measurements': [{'value': '3.47', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Day 15: Quality of life (n=106)', 'categories': [{'measurements': [{'value': '3.44', 'spread': '1.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 15', 'description': '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.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydromorphone Hydrochloride Oral Osmotic System', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Paticipants did not cooperate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Choice by participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydromorphone HCl OROS', 'description': 'Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.94', 'spread': '11.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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).', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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).', 'unitOfMeasure': 'Participants'}], 'populationDescription': '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).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2009-10-29', 'resultsFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2009-10-29', 'lastUpdatePostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-09', 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain', 'timeFrame': 'Day 15', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Frequency of Experiencing Breakthrough Pain', 'timeFrame': 'Day 1 and Day 15', 'description': '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.'}, {'measure': 'Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15', 'timeFrame': 'Baseline and Day 15', 'description': '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.'}, {'measure': 'Pain Intensity Score', 'timeFrame': 'Day 3 and Day 13', 'description': '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.'}, {'measure': 'Global Assessment of Overall Efficacy of Study Drug by Investigator', 'timeFrame': 'Day 15', 'description': "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'."}, {'measure': 'Global Assessment of Overall Efficacy of Study Drug by Participant', 'timeFrame': 'Day 15', 'description': "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'."}, {'measure': "Participant's Preferences Along With Reasons", 'timeFrame': 'Day 15', 'description': '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.'}, {'measure': 'Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score', 'timeFrame': 'Day 15', 'description': "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."}, {'measure': 'European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score', 'timeFrame': 'Day 1 and Day 15', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hydromorphone hydrochloride Oral Osmotic System', 'Jurnista'], 'conditions': ['Cancer', 'Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer participants administering only strong oral opioid analgesic for cancer pain control\n* Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)\n* Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators\n* Abstinent or surgically sterile female participants\n\nExclusion Criteria:\n\n* Participants with cancer pain who are potentially unresponsive to narcotic analgesics\n* Participants with presence or history of drug or alcohol abuse within the past 6 months\n* Participants with hypersensitivity to hydromorphone HCl\n* Participants with history of colectomy (surgery to remove part or all of the colon)\n* 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'}, 'identificationModule': {'nctId': 'NCT01006356', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CR015694'}, 'secondaryIdInfos': [{'id': '42801PAI4006'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)', 'description': 'Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks.', 'interventionNames': ['Drug: Hydromorphone HCl OROS']}], 'interventions': [{'name': 'Hydromorphone HCl OROS', 'type': 'DRUG', 'description': 'Hydromorphone HCl OROS 8 mg once daily for 2 weeks.', 'armGroupLabels': ['Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen Korea, Ltd., Korea Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Korea, Ltd., Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}