EFFECT OF PENTOXIFYLLINE ON THE TIGHT JUNCTIONS (TJs) OF THE INTESTINAL MUCOSA IN PATIENTS WITH IRRITABLE BOWEL SYNDROME (IBS).

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: Trade Name: HEMOVÁS Product Name: pentoxifylline Product Code: pentoxifylline Pharmaceutical Form: Capsule INN or Proposed INN: Pentoxifilline Current Sponsor code: 2010‐024028‐24 Other descriptive name: Pentoxifilline Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Pharmaceutical form of the placebo: Tablet for oral suspension Route of administration of the placebo: Buccal use CONDITION: IRRITABLE BOWEL SYNDROME (IBS) generates tomach pain and changes in depositions number and consistency. IBS has a high prevalence in Digestive consultations. In spite of this, we haven´t good treatments to avoid cronic and recurrents symptoms. Therapeutic area: Diseases [C] ‐ Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] PRIMARY OUTCOME: Main Objective: Determine the therapeutic effectiveness of treatment with oral pentoxifiline in the severity and the clinic evolution of patient with IBS. Primary end point(s): Main variable will be the assessment of IBS clinic evolution and severity. Secondary Objective: Research the effect os treatment with pentoxifiline Timepoint(s) of evaluation of this end point: 1 year SECONDARY OUTCOME: Secondary end point(s): assessment of biologic effect of treatment with PTX Timepoint(s) of evaluation of this end point: 1 year INCLUSION CRITERIA: P atients from 18 to 65 years old and with capacity to give informed consent. The patients with IBS are belong that patients who come to Digestive consultation from our center. Patients must have a monitoring at least 6 months before the inclussion. Achive the Roma III criterions for IBS (Gastroenterology 2006;130:1377‐90) with moderate‐severe gravity according to Francis modificated scale. Patients could not have any alergic pathology or gastrointestinals illness. Women with fertile age no pregnant (proven blood or urine test in visit of selection) and use methods of contraception at least from 14 days before first dose of medicine until 14 days after last dose of medicine. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 59 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: c1eda1181e2fe0dd199d5fb33ac1e1982ffc3820
First added on: Aug 22, 2024