NCT01542268

Brief Summary

The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

September 23, 2011

Last Update Submit

March 5, 2012

Conditions

Irritable Bowel Syndrome

Keywords

pentoxifyllinetight junction signallingintestinal epithelial barrierirritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

  • 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. "

    3 months from the first day of treatment

Secondary Outcomes (1)

  • Mucosal byopsies

    3 months from the first day of treatment

Study Arms (2)

pentoxifylline

ACTIVE COMPARATOR
Drug: pentoxifylline

pentoxifylline placebo

PLACEBO COMPARATOR
Drug: pentoxifylline placebo

Interventions

pentoxifyllineDRUG

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
pentoxifylline
pentoxifylline placeboDRUG

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
pentoxifylline placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years old
  • Most of the patient with IBS will be chose between the patients who go to Digestive System ambulatory external medical office from our Center.
  • Be studied and with clinical monitoring al least 6 months before be included.
  • Fulfill with Roma III Criteria for IBS (Gastroenterology 2006;130:1377-90) with moderate-severe seriousness according to Modification Francis Scale

You may not qualify if:

  • weeks before colon biopsia, any patient cann´t take salicylates, NSAID, antibiotics,anticholinergics,opiates or any other medication / product for asintomatic treatment of diarrea.
  • months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive
  • months before colon biopsia, any patient cann´t recive radiotherapy or chemotherapy.
  • Pentoxifilina Alergic Reactions
  • Pregnants
  • Grave kidney failure
  • Grave Hepatic failure
  • Menthal or legal disability to sign the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, S/c Tenerife, 38320, Spain

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • LAURA RAMOS, MD

    COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LAURA RAMOS, MD

CONTACT

+34 922675557laura7ramos@gmail.com

ANA ALDEA, MD

CONTACT

+34922678115a.aldea@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2011

First Posted

March 2, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

ES(1)