Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT02930005
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2016-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008469', 'term': 'Meclofenamic Acid'}, {'id': 'D010426', 'term': 'Pentosan Sulfuric Polyester'}], 'ancestors': [{'id': 'D054361', 'term': 'Fenamates'}, {'id': 'D062367', 'term': 'ortho-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Olaoluwa.O.Okusaga@uth.tmc.edu', 'phone': '(713) 741-3952', 'title': 'Dr. Olaoluwa O. Okusaga', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Meclofenamic Acid', 'description': '150mg meclofenamic acid daily for 8 weeks\n\nMeclofenamic acid', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pentosan Polysulfate Sodium', 'description': '300mg of pentosan polysulfate sodium daily for 8 weeks\n\nPentosan polysulfate sodium', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meclofenamic Acid', 'description': '150mg meclofenamic acid daily for 8 weeks\n\nMeclofenamic acid'}, {'id': 'OG001', 'title': 'Pentosan Polysulfate Sodium', 'description': '300mg of pentosan polysulfate sodium daily for 8 weeks\n\nPentosan polysulfate sodium'}], 'classes': [{'categories': [{'measurements': [{'value': '31.96', 'groupId': 'OG000'}, {'value': '0.96', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, 8 weeks', 'description': 'A higher composite score on the NCTB indicates better cognitive performance. The NCTB consists of 7 tests and 8 sub-scores, and the NIH Toolbox software calculates total composite score by averaging the normalized scores of each subscale and then deriving scale scores. The "NIH Toolbox Scoring and Interpretation Guide" (found online) doesn\'t indicate a total composite score range (because the score ranges are infinite), but describes scoring as follows: To get a normalized composite score, the score of the test taker is compared to the scores in the NIH Toolbox nationally representative normative sample. The mean score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.', 'unitOfMeasure': 'score', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meclofenamic Acid', 'description': '150mg meclofenamic acid daily for 8 weeks\n\nMeclofenamic acid'}, {'id': 'OG001', 'title': 'Pentosan Polysulfate Sodium', 'description': '300mg of pentosan polysulfate sodium daily for 8 weeks\n\nPentosan polysulfate sodium'}], 'classes': [{'categories': [{'measurements': [{'value': '-11', 'groupId': 'OG000'}, {'value': '-22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, 8 weeks', 'description': 'Change in the Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks. The range of scores on the PANSS is 30 to 210, with higher scores associated with better outcomes.', 'unitOfMeasure': 'score', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meclofenamic Acid', 'description': '150mg meclofenamic acid daily for 8 weeks\n\nMeclofenamic acid'}, {'id': 'FG001', 'title': 'Pentosan Polysulfate Sodium', 'description': '300mg of pentosan polysulfate sodium daily for 8 weeks\n\nPentosan polysulfate sodium'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Completed 2 Weeks', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'comment': 'Completed the 8 week study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Meclofenamic Acid', 'description': '150mg meclofenamic acid daily for 8 weeks\n\nMeclofenamic acid'}, {'id': 'BG001', 'title': 'Pentosan Polysulfate Sodium', 'description': '300mg of pentosan polysulfate sodium daily for 8 weeks\n\nPentosan polysulfate sodium'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '26', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '24.6', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2016-09-28', 'resultsFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-25', 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score', 'timeFrame': 'baseline, 8 weeks', 'description': 'A higher composite score on the NCTB indicates better cognitive performance. The NCTB consists of 7 tests and 8 sub-scores, and the NIH Toolbox software calculates total composite score by averaging the normalized scores of each subscale and then deriving scale scores. The "NIH Toolbox Scoring and Interpretation Guide" (found online) doesn\'t indicate a total composite score range (because the score ranges are infinite), but describes scoring as follows: To get a normalized composite score, the score of the test taker is compared to the scores in the NIH Toolbox nationally representative normative sample. The mean score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.'}], 'secondaryOutcomes': [{'measure': 'Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Change in the Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks. The range of scores on the PANSS is 30 to 210, with higher scores associated with better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychotic', 'Schizophrenia', 'Schizoaffective', 'Bipolar'], 'conditions': ['Psychotic Disorders', 'Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility of administering meclofenamic acid or pentosan polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic disorder. Half of participants will receive meclofenamic acid, while the other half will receive polysulfate sodium.', 'detailedDescription': 'Chronic, low-grade brain inflammation is involved in the development of schizophrenia and other psychotic disorders. Medications with anti-inflammatory properties, like meclofenamic acid and pentosan polysulfate may help to reduce brain inflammation and serve as a treatment of psychotic disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorders, unspecified schizophrenia spectrum and other psychotic disorders\n* Negative pregnancy test in females of childbearing age\n\nExclusion Criteria:\n\n* Urine drug screen positive for psychostimulants such as cocaine, amphetamines and ecstasy\n* Any infection, neoplasm, autoimmune disease or other primary inflammatory condition (3) Previous diagnosis of intellectual disability or dementia\n* Current treatment with heparin\n* Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate sodium\n* Current or anticipated corticosteroid use\n* History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal bleeding\n* Those on warfarin or any anticoagulant\n* Current treatment with lithium or asthma medication\n* Individuals with pre-existing liver, cardiac, or kidney disease'}, 'identificationModule': {'nctId': 'NCT02930005', 'briefTitle': 'Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Pilot Open-label Trial of Pentosan Polysulfate Sodium and Meclofenamic Acid As Adjunctive Treatments in Patients With Psychotic Disorders', 'orgStudyIdInfo': {'id': 'HSC-MS-15-0329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meclofenamic acid', 'description': '150mg meclofenamic acid daily for 8 weeks', 'interventionNames': ['Drug: Meclofenamic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Pentosan polysulfate sodium', 'description': '300mg of pentosan polysulfate sodium daily for 8 weeks', 'interventionNames': ['Drug: Pentosan polysulfate sodium']}], 'interventions': [{'name': 'Meclofenamic acid', 'type': 'DRUG', 'otherNames': ['Meclomen'], 'armGroupLabels': ['Meclofenamic acid']}, {'name': 'Pentosan polysulfate sodium', 'type': 'DRUG', 'otherNames': ['Elmiron', 'Hemoclar', 'Fibrase', 'Anarthron'], 'armGroupLabels': ['Pentosan polysulfate sodium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}