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.
Conditions
Interventions
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 na
Sponsors
Hospital Universitario de Canarias
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Patients can not take Salicylates, NSAIDs, antibiotics,anticholinergic, Opiates or any other medication or product use for diarrea sintomatic treathment two weeks before biopsia. Besides, others medications as corticoid, antihistamine or immunosuppressives can not be taken 3 months before the colon biopsia. Patients who had recibed radiotherapy or chemotherapy 6 months before the study. Alergic reactions to pentoxifiline, pregnancy, kidney or hepatic severe failure or any mental or legal disability to sign informed consent . Pregnant or while breastfeeding. All cases where medicine in research is contraindicated by medicine technical data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the therapeutic effectiveness of treatment with oral pentoxifiline in the severity and the clinic evolution of patient with IBS.;Secondary Objective: Research the effect os treatment with pentoxifiline;Primary end point(s): Main variable will be the assessment of IBS clinic evolution and severity.;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): assessment of biologic effect of treatment with PTX;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Spain
Contacts
Public ContactUCICEC
FUNDACIÓN RAFAEL CLAVIJO
Outcome results
None listed