Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT00444093
Status:
TERMINATED
Last Update Posted:
2023-05-11
First Post:
2007-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D004751', 'term': 'Enteritis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'bad recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2008-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2007-03-06', 'studyFirstSubmitQcDate': '2007-03-06', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Efficacy', 'timeFrame': '90 days', 'description': 'In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhoea of grade \\> 2 is successfully averted during (cancer) therapy.'}], 'secondaryOutcomes': [{'measure': 'Quality of life EORTC-QLQ C30', 'timeFrame': '90 days', 'description': 'Quality of life will be assessed with the EORTC-QLQ C30 questionnaire'}, {'measure': 'Diarrhea Assessment', 'timeFrame': '90 days', 'description': 'The quality and quantity of diarrhea will be assessed with a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radiation therapy', 'diarrhea', 'enteritis', 'supportive therapy', 'therapy associated diarrhea', 'therapy associated enteritis', 'radiation therapy of the small pelvis'], 'conditions': ['Diarrhea', 'Enteritis', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a common problem in multimodal cancer therapy. We investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients who will undergo a percutaneous radiation therapy in the area of the small pelvis. This includes patients with following malignancies: rectal carcinoma, prostate carcinoma, endometrial carcinoma, cervix carcinoma.\n* Diarrhea grade 1 and grade 2 (Classification NCI-CTCAE Version 3.0)\n* ECOG-Grade 0-2\n* Enlightenment and written declaration of consent to the participation.\n\nExclusion Criteria:\n\n* Pregnant patients or patients in lactation period.\n* Severe dysfunction of liver or kidneys\n* Injury or illness of brain e.g. increased intracranial pressure, cerebral arteriosclerosis\n* Epilepsy\n* Hypersensitivity to components of loperamide or tincture of opium\n* Ileus\n* Toxic megacolon\n* Pseudomembranous colitis/ antibiotic-associated colitis\n* Diarrhea associated with fever and bloody stools\n* Acute increase of colitis ulcerous or bacterial colitis caused by invasive pathogenes\n* Severe respiratory dysfunction or severely limited lung function e.g. bronchial asthma, bronchitis\n* Dysfunctional draining of biliary area, biliary colics.\n* Concomitant or earlier addiction of alcohol or opiates\n* Severe heart disease\n* Pheochromocytoma\n* Acute hepatic porphyria\n* Cor pulmonale\n* Morbus Addison\n* Severe hypothyroidism\n* Organisational problems or circumstances which prevent a complete collection of required data\n* Artificial anus\n* Participation in a clinical trial within the last 30 days before involvement\n* Participation in an other clinical trial at the same time'}, 'identificationModule': {'nctId': 'NCT00444093', 'acronym': 'Loop', 'briefTitle': 'Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -', 'organization': {'class': 'OTHER', 'fullName': 'Philipps University Marburg'}, 'officialTitle': 'Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium', 'orgStudyIdInfo': {'id': '2006-002948-28'}, 'secondaryIdInfos': [{'id': 'KKS-73-05'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opii normata treatment', 'description': 'Treamtment with opii normata in case of diarrhea', 'interventionNames': ['Drug: Opii normata treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Loperamid Treatment', 'description': 'Treatment with Loperamid in case of diarrhea', 'interventionNames': ['Drug: Loperamid Treatment']}], 'interventions': [{'name': 'Opii normata treatment', 'type': 'DRUG', 'description': 'After beginning of diarrhea grade 1:\n\n5 drops tincture of opium three times a day\n\nAfter beginning of diarrhea grade 2:\n\nIntensive therapy with 15 drops tincture of opium three times a day.', 'armGroupLabels': ['Opii normata treatment']}, {'name': 'Loperamid Treatment', 'type': 'DRUG', 'description': 'All patients who receive as a result of randomisation loperamide\n\nAfter beginning of diarrhea grade 1:\n\nInitial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day.\n\nAfter beginning of diarrhea grade 2:\n\nIntensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day.', 'armGroupLabels': ['Loperamid Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael Bieker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'center of radiology, departement of radiation therapy, clinical center Giessen and Marburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philipps University Marburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maros Arznei GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}