Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 6:27 AM
Study NCT ID:
NCT01542268
Status:
UNKNOWN
Last Update Posted:
2012-03-06
First Post:
2011-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2011-09-23', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of abdominal pain', 'timeFrame': '3 months from the first day of treatment', 'description': 'Clinical endpoint:\n\nAverage daily severity of abdominal pain on a 0-10 scale \\[ Time Frame: Week 0 to week 12 \\] \\[ Designated as safety issue: No \\] Days with urgency \\[ Time Frame: Week 0 to week 12 \\] \\[ Designated as safety issue: No \\] Mean stool consistency using Bristol Stool Form Score \\[ Time Frame: Week 0 to week 12 \\] \\[ Designated as safety issue: No \\] Global satisfaction with control of IBS symptoms as assessed from the answer to the question "Have you had satisfactory relief of your IBS symptoms this week? Yes / No. "'}], 'secondaryOutcomes': [{'measure': 'Mucosal byopsies', 'timeFrame': '3 months from the first day of treatment', 'description': 'Effect of pentoxifylline treatment from mucosal byopsies on:\n\n1. epithelial morphology;\n2. mucosal immune cell subsets;\n3. changes of gene expression of genes related to intestinal epithelial barrier component( tight junctions)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pentoxifylline', 'tight junction signalling', 'intestinal epithelial barrier', 'irritable bowel syndrome'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.', 'detailedDescription': 'Disruption of the intestinal epithelial barrier is part of the pathophysiology of IBS favoring immune activation present in the mucosa of these patients and the development of symptoms in IBS. To evaluate the effect of treatment with pentoxifylline (PTX) in patients with IBS related to clinical response and modulation of the components of the epithelial barrier at the level of intestinal mucosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years old\n* Most of the patient with IBS will be chose between the patients who go to Digestive System ambulatory external medical office from our Center.\n* Be studied and with clinical monitoring al least 6 months before be included.\n* Fulfill with Roma III Criteria for IBS (Gastroenterology 2006;130:1377-90) with moderate-severe seriousness according to Modification Francis Scale\n\nExclusion Criteria:\n\n* 2 weeks before colon biopsia, any patient cann´t take salicylates, NSAID, antibiotics,anticholinergics,opiates or any other medication / product for asintomatic treatment of diarrea.\n* 3 months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive\n* 6 months before colon biopsia, any patient cann´t recive radiotherapy or chemotherapy.\n* Pentoxifilina Alergic Reactions\n* Pregnants\n* Grave kidney failure\n* Grave Hepatic failure\n* Menthal or legal disability to sign the consent'}, 'identificationModule': {'nctId': 'NCT01542268', 'acronym': 'IBS-PTX', 'briefTitle': 'Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario de Canarias'}, 'officialTitle': 'Effect of Pentoxifylline on Tight Junctions of Intestinal Mucosa in Patients With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'IBS-PTX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pentoxifylline', 'interventionNames': ['Drug: pentoxifylline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'pentoxifylline placebo', 'interventionNames': ['Drug: pentoxifylline placebo']}], 'interventions': [{'name': 'pentoxifylline', 'type': 'DRUG', 'otherNames': ['A'], 'description': 'Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.', 'armGroupLabels': ['pentoxifylline']}, {'name': 'pentoxifylline placebo', 'type': 'DRUG', 'otherNames': ['B'], 'description': 'Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months.', 'armGroupLabels': ['pentoxifylline placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'state': 'S/c Tenerife', 'country': 'Spain', 'contacts': [{'name': 'LAURA RAMOS, MD', 'role': 'CONTACT', 'email': 'laura7ramos@gmial.com', 'phone': '+34 922675557'}, {'name': 'ANA ALDEA, MD', 'role': 'CONTACT', 'email': 'a.aldea@gmail.com', 'phone': '+34922678115'}, {'name': 'LAURA RAMOS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complejo Hospitalario Universitario de Canarias', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}], 'centralContacts': [{'name': 'LAURA RAMOS, MD', 'role': 'CONTACT', 'email': 'laura7ramos@gmail.com', 'phone': '+34 922675557'}, {'name': 'ANA ALDEA, MD', 'role': 'CONTACT', 'email': 'a.aldea@gmail.com', 'phone': '+34922678115'}], 'overallOfficials': [{'name': 'LAURA RAMOS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario de Canarias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}