Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-26 @ 12:51 AM
Study NCT ID:
NCT01812733
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2013-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2013-03-14', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '8 Weeks', 'description': 'Two visits performed over 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain', 'Opioid Induced Constipation']}, 'descriptionModule': {'briefSummary': 'The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients have severe pain treated with opioids and will be enrolled at different clinics in Sweden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male or non-pregnant female ≥18 years of age\n* Malignant or non-malignant opioid sensitive pain\n* Must sign an informed consent form (ICF)\n* Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts)\n* Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect\n* BFI ≥30 and state a discomfort caused by the constipation at screening\n* Ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months\n\nExclusion criteria:\n\n* History of, or on-going, abuse of alcohol and/or drugs\n* Inability to read and understand written instructions, ICF or questionnaires\n* Constipation not related to opioid use\n* Unsuitable patient for other reason(s) in the opinion of the investigator\n* Inpatients, if admission and/or discharge is expected during study period'}, 'identificationModule': {'nctId': 'NCT01812733', 'briefTitle': 'Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma AB'}, 'officialTitle': 'An Observational Study of Quality of Life, Resource Use and Costs Associated With Treatment of Severe Pain - a Comparison of a Combination of Oxycodone and Naloxone (Targiniq) Versus Oxycodone and Laxatives', 'orgStudyIdInfo': {'id': 'OXN9513'}}, 'contactsLocationsModule': {'locations': [{'city': 'Örebro', 'country': 'Sweden', 'facility': 'Rehabiliteringsmedicinska kliniken', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}