Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-25 @ 5:55 PM
Study NCT ID:
NCT01532895
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2012-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-15', 'studyFirstSubmitDate': '2012-02-10', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients', 'timeFrame': 'Baseline and at approximately Day 57'}], 'secondaryOutcomes': [{'measure': 'Changes in the Karnofsky Performance Rating Scale (KPRS)', 'timeFrame': 'Baseline, and at approximately Days 29 and 57', 'description': 'The KPRS measures the physical functions of cancer patients, and indicates the feasibility of daily life by 10% units from 0% (death) to 100% (normal status in which patients can do activities to the level before disease without limitations).'}, {'measure': 'Change in pain relief (%)', 'timeFrame': 'Baseline, and at approximately Days 29 and 57', 'description': 'How much pain was relieved by the pain therapy or medication for the last 24 hours, using %: 0%= nothing reduced and 100%= completely reduced.'}, {'measure': 'Frequency of awakening', 'timeFrame': 'Baseline, and at approximately Days 29 and 57', 'description': 'Check whether patients experienced awakening during sleep caused by pain for the last 1 week or not, and measure the frequency (1 = once, 2 = twice, 3 = 3 times, 4 = more than 4 times, 5 = not woken, 6 = never slept).'}, {'measure': 'Level of sleep inconvenience', 'timeFrame': 'Baseline, and at approximately Days 29 and 57', 'description': 'Measure the level of sleep inconvenience that patients experienced due to pain for the last 1 week using the Numeric Rating Scale (NRS); 0 = not causing inconvenience, 10 = completely causing inconvenience.'}, {'measure': 'Satisfaction with sleep', 'timeFrame': 'Baseline, and at approximately Days 29 and 57', 'description': 'Indicate the overall satisfaction with sleep by improving sleep disturbance caused by pain for the last 1 week using the Numeric Rating Scale (0 "never satisfied" on the left end; 10 "very satisfied" on the right end).'}, {'measure': 'Quality of life assessment measured by the EORTC QLQ-C15 PAL', 'timeFrame': 'Baseline, and at approximately Days 29 and 57', 'description': 'The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15 (Quality of Life Questionnaire Core 15) is a commonly used questionnaire to assess the quality of life of cancer patients taking paliative medicine. This questionnaire consists of questions measuring physical, role, emotional, cognitive and social functions, and answers are given based on a 4-point scale, from 1 (not at all) to 4 (very much so).'}, {'measure': "Investigator's Global Assessment", 'timeFrame': 'At approximately Days 29 and 57', 'description': "The investigator's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the investigator from the investigator's point of view as 1 = not effective, 2 = normal l, 3 = effective, 4 very effective, and 5 = extremely effective."}, {'measure': "Patient's Global Assessment", 'timeFrame': 'At approximately Days 29 and 57', 'description': "The patient's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the patient from the patient's point of view as 1 = not effective, 2 = normal, 3 = effective, 4 = very effective, and 5 = extremely effective."}, {'measure': 'CGI-I (Clinical Global Impression - Improvement)', 'timeFrame': 'At approximately Days 29 and 57', 'description': 'Evaluate how much patients have improved compared with the conditions of patients at baseline, from 1 (very much improved) to 7 (greatly deteriorated).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Cancer pain', 'Hydromorphone', 'Hydromorphone OROS', 'Narcotic analgesics', 'Opioid-naive'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.', 'detailedDescription': "This is a multicenter, prospective, open-label (all people know the identity of the intervention) and observational study. Patients selected for the proposed study are patients complaining of cancer pain who visit or are hospitalized at the research centers during the study, who are not being treated with strong continuous opioid (narcotic medication used against the pain), and who require cancer pain control with hydromorphone, at the investigator's discretion. The study will evaluate the changes in pain relief, level of sleep deprivation, and the patients' quality of life before and after administration of hydromorphone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Korean cancer patients having cancer pain who visit or are hospitalized at the research centers during the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: - Patients who complain of cancer pain and who require administration of hydromorphone HCl - Patients who can follow the requirements of the overall study, including completion of filling out the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, at the investigator's discretion - Signed informed consent Exclusion Criteria: - Patients who received strong continuous narcotic analgesics (eg morphine, fentanyl, oxycodone, hydromorphone) within 4 weeks prior to administration of the study drug - Patients who have a medical history of receiving drugs in the past or currently, or of drug abuse - Patients who did not agree to conduct the approved methods for contraception during the study - Patients who have sustained injuries in physical functions or diseases which may cause abnormalities in absorbing the study drug, excessive accumulation and metabolic or elimination disorder - Patients who are receiving Monoamine Oxidase Inhibitors (MAO) inhibitors or who are within 2 weeks from discontinuation - Patients who need to be excluded based on precautions in the user manual of the study drug, notice and contradictions, at the investigator's discretion"}, 'identificationModule': {'nctId': 'NCT01532895', 'briefTitle': 'Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': 'Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study', 'orgStudyIdInfo': {'id': 'CR100741'}, 'secondaryIdInfos': [{'id': '42801PAI4013', 'type': 'OTHER', 'domain': 'Janssen Korea, Ltd., Korea'}, {'id': 'HYD-KOR-5011', 'type': 'OTHER', 'domain': 'Janssen Korea, Ltd., Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hydromorphone HCI OROS', 'interventionNames': ['Drug: Hydromorphone HCI OROS']}], 'interventions': [{'name': 'Hydromorphone HCI OROS', 'type': 'DRUG', 'description': 'type= exact number, unit= mg, number=4, form= tablet, route= oral use. One tablet administered once a day. The dose may be increased if the level of pain increases or if the pain-killing effect is insufficient.', 'armGroupLabels': ['Hydromorphone HCI OROS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ansan', 'country': 'South Korea', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheongju-si', 'country': 'South Korea', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Daegu', 'country': 'South Korea', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Hwasun Gun', 'country': 'South Korea'}, {'city': 'Incheon', 'country': 'South Korea', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Pusan', 'country': 'South Korea', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seognam-Si, Kyungki-Do', 'country': 'South Korea'}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Wonju-Shi', 'country': 'South Korea'}], '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'}}}}