Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2026-01-03 @ 2:51 AM
Study NCT ID:
NCT01197261
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2010-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To estimate the patient's average pain during treatment with OXN PR compared with placebo", 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient questionnaires', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'keywords': ['Severe pain', 'Bladder Pain Syndrome', 'Interstitial Cystitis', 'Painful Bladder Syndrome', 'Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome'], 'conditions': ['Interstitial Cystitis', 'Painful Bladder Syndrome', 'Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXN2503', 'label': 'Results available on website'}]}, 'descriptionModule': {'briefSummary': 'The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.', 'detailedDescription': 'The study consists of a screening period followed by randomisation of the patients in a 1:1 ratio to OXN PR treatment or placebo treatment in a double blind fashion. The double blind phase will last for 8 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* History of severe pain due to Bladder Pain Syndrome (BPS) for at least 6 months\n* Subject's treatment of pain due to BPS is insufficient\n* Subjects must not have received opioid containing medication in the last 6 months\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating\n* Subjects with any contraindication/history of hypersensitivity to oxycodone, naloxone, paracetamol, related products or other ingredients\n* Subjects with any situation in which opioids are contraindicated like severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma or paralytic ileus\n* Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results\n* Abnormal aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatise levels (\\> 3 times the upper limit of normal), gamma glutamyl transpeptidase \\> 3 times the upper limit of normal\n* Abnormal total bilirubin and/or creatinine level(s)"}, 'identificationModule': {'nctId': 'NCT01197261', 'briefTitle': 'OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma Research GmbH & Co KG'}, 'officialTitle': 'An Exploratory, Randomised, Double-blind, Placebo-controlled, Parallel Group, Pilot Study to Assess the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets (OXN PR) Compared to Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome.', 'orgStudyIdInfo': {'id': 'OXN2503'}, 'secondaryIdInfos': [{'id': '2009-018118-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OXN PR', 'description': 'Oxycodone Naloxone tablets', 'interventionNames': ['Drug: Oxycodone naloxone prolonged release tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLA', 'interventionNames': ['Drug: Placebo tablets']}], 'interventions': [{'name': 'Oxycodone naloxone prolonged release tablets', 'type': 'DRUG', 'description': '2 tablets/ day', 'armGroupLabels': ['OXN PR']}, {'name': 'Placebo tablets', 'type': 'DRUG', 'description': '2 tablets/ day', 'armGroupLabels': ['PLA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Frankfurt', 'country': 'Germany', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma Research GmbH & Co KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}