A Phase 4 interventional study of pentoxifylline and pentoxifylline placebo in Irritable Bowel Syndrome, sponsored by Hospital Universitario de Canarias. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-06.
Sponsored by Hospital Universitario de Canarias · Phase 4, Interventional, and Treatment
The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's planned enrollment of 59 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Hospital Universitario de Canarias is the lead sponsor of 30 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: pentoxifylline
Drug: pentoxifylline placebo
Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.
Also known as: A
Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months.
Also known as: B
Severity of abdominal pain
Clinical endpoint: Average 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. "
Time frame: 3 months from the first day of treatment
Mucosal byopsies
Effect of pentoxifylline treatment from mucosal byopsies on: 1. epithelial morphology; 2. mucosal immune cell subsets; 3. changes of gene expression of genes related to intestinal epithelial barrier component( tight junctions)
Time frame: 3 months from the first day of treatment
This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Hospital Universitario de Canarias