Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-29 @ 7:37 AM
Study NCT ID:
NCT01570634
Status:
TERMINATED
Last Update Posted:
2013-03-08
First Post:
2012-04-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013035', 'term': 'Spasm'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077250', 'term': 'Calcium Aluminosilicate'}], 'ancestors': [{'id': 'D000538', 'term': 'Aluminum Silicates'}, {'id': 'D000537', 'term': 'Aluminum Oxide'}, {'id': 'D017607', 'term': 'Aluminum Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017640', 'term': 'Silicates'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D012824', 'term': 'Silicic Acid'}, {'id': 'D012822', 'term': 'Silicon Dioxide'}, {'id': 'D017655', 'term': 'Silicon Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rscruggs@salientpharmaceuticals.com', 'phone': '7135899859', 'title': 'Richard scruggs', 'organization': 'Salient Pharmaceuticals Incorporated'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated early for slow enrollment. Only 2 patients were enrolled during the open period. One of the two took less than 50% of the prescribed study drug. The results are not meaningful.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during active study period of 6 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label CASAD', 'description': 'Treatment with CASAD for 14 days', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'unrelated to study drug, patient recovered with no residual effect.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'notes': 'probably related to study drug, patient recovered, no action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Burping/Gas', 'notes': 'Possible relationship to study drug, no action taken, patient recovered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dark urine', 'notes': 'No action taken, patient recovered with no residual effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resolution of Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label CASAD', 'description': 'Treatment with CASAD for 14 days'}], 'timeFrame': '42 days', 'description': 'To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early due to slow enrollment. Of the 2 patients enrolled, one took less than 50% of the prescribed study drug. The results are not evaluable.'}, {'type': 'SECONDARY', 'title': 'Stools Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label CASAD', 'description': 'Treatment with CASAD for 14 days'}], 'timeFrame': '14 days', 'description': 'Compare the number of liquid stools per day during treatment period', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.'}, {'type': 'SECONDARY', 'title': 'Resolution of Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label CASAD', 'description': 'Treatment with CASAD for 14 days'}], 'timeFrame': '14 days', 'description': 'Compare time to resolution of abdominal pain', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.'}, {'type': 'SECONDARY', 'title': 'Absence of Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label CASAD', 'description': 'Treatment with CASAD for 14 days'}], 'timeFrame': '42 days', 'description': 'Compare sustained clinical response', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.'}, {'type': 'SECONDARY', 'title': 'Side-effects and Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label CASAD', 'description': 'Treatment with CASAD for 14 days'}], 'timeFrame': '42 days', 'description': 'Compare side-effects and complications', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label CASAD', 'description': 'Treatment with Calcium Aluminosilicate Anti-Diarrheal (CASAD) for 14 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruiting was managed by Scott \\& White'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label CASAD', 'description': 'Treatment with CASAD for 14 days'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '13.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Study was stopped for slow enrollment - only 2 patients, no evaluable results', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-03', 'studyFirstSubmitDate': '2012-04-01', 'resultsFirstSubmitDate': '2012-12-29', 'studyFirstSubmitQcDate': '2012-04-03', 'lastUpdatePostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-03', 'studyFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of Diarrhea', 'timeFrame': '42 days', 'description': 'To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).'}], 'secondaryOutcomes': [{'measure': 'Stools Per Day', 'timeFrame': '14 days', 'description': 'Compare the number of liquid stools per day during treatment period'}, {'measure': 'Resolution of Abdominal Pain', 'timeFrame': '14 days', 'description': 'Compare time to resolution of abdominal pain'}, {'measure': 'Absence of Relapse', 'timeFrame': '42 days', 'description': 'Compare sustained clinical response'}, {'measure': 'Side-effects and Complications', 'timeFrame': '42 days', 'description': 'Compare side-effects and complications'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Clostridium difficile', 'infection', 'diarrhea', 'cramping'], 'conditions': ['Diarrhoea, Clostridium Difficile']}, 'descriptionModule': {'briefSummary': 'Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically occurs after a patient has received antibiotics.\n\nIn vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would likely occur in conjunction with neutralization of C. difficile toxins A\\&B by CASAD. Computer modeling of CASAD performed by Phillips et al. at Texas A\\&M University supports this hypothesis.\n\nThe investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care therapy will reduce the duration and severity of diarrhea and other symptoms in patients with C. difficile infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* C. difficile-associated diarrhea at the time of enrollment\n* 18 years old and up\n* Ability to take oral medications\n* Negative urine pregnancy test for women of childbearing age\n* Must have the ability to understand and the willingness to provide a written informed consent to participate in the study\n\nExclusion Criteria:\n\n* History of known allergy to silicates\n* Patients with signs of toxic megacolon, peritonitis, pseudomembranous colitis or bowel perforation\n* Patients with hypotension (systolic blood pressure \\< 90 mm Hg) or septic shock requiring pressors\n* Patients with other known causes of diarrhea or colitis\n* Pregnancy or lactation\n* History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up\n* Participation in any other study where the subject is actively taking investigational medication within the last 30 days\n* More than 5 doses of metronidazole or oral vancomycin prior to starting on study drug for the current C. difficile diagnosis. Administration of metronidazole or oral vancomycin for treatment of prior C. difficile diagnosis is not exclusionary as some patients may be experiencing a relapse of C. difficile.\n* Any other antibiotic, toxin-binding agent or fecal transplant used for the treatment of C. difficile prior to or added to the subject's standard-of-care treatment regimen. Use of intravenous vancomycin is not exclusionary."}, 'identificationModule': {'nctId': 'NCT01570634', 'briefTitle': 'Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Salient Pharmaceuticals Incorporated'}, 'officialTitle': 'Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection', 'orgStudyIdInfo': {'id': 'SAL-2011-01PCL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label CASAD', 'description': 'Treatment with CASAD for 14 days', 'interventionNames': ['Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)']}], 'interventions': [{'name': 'Calcium Aluminosilicate Anti-Diarrheal (CASAD)', 'type': 'DRUG', 'otherNames': ['CASAD'], 'description': 'CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up', 'armGroupLabels': ['Open Label CASAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White Memorial Hospital', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'overallOfficials': [{'name': 'Aarthi Narasimhan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scott & White Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salient Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Scott and White Hospital & Clinic', 'class': 'OTHER'}, {'name': 'Texas A&M University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}