Irritable Bowel SyndromePhase 4IBS-PTXNCT01542268
Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS)
A Phase 4 study testing pentoxifylline in people with Irritable Bowel Syndrome, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- 3 months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive
- 6 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, S/c Tenerife, 38320
LAURA RAMOS, MD, +34 922675557, laura7ramos@gmial.com
ANA ALDEA, MD, +34922678115, a.aldea@gmail.com
About this study
Official title: Effect of Pentoxifylline on Tight Junctions of Intestinal Mucosa in Patients With Irritable Bowel Syndrome
The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.
Read the detailed description
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- pentoxifylline, pentoxifylline placebo
- Keywords
- pentoxifylline, tight junction signalling, intestinal epithelial barrier, irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentoxifyllineDrug
Also called A
Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.
pentoxifylline placeboDrug
Also called B
Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months.
| Study group | Role | What they receive |
|---|---|---|
| pentoxifylline | Active comparator | Not described Receives: Drug: pentoxifylline |
| pentoxifylline placebo | Placebo comparator | Not described Receives: Drug: pentoxifylline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. "
Measured: 3 months from the first day of treatment
Secondary outcomes (1)
Mucosal byopsies
Effect of pentoxifylline treatment from mucosal byopsies on:
- epithelial morphology;
- mucosal immune cell subsets;
- changes of gene expression of genes related to intestinal epithelial barrier component( tight junctions)
Measured: 3 months from the first day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAURA RAMOS, MD, Principal investigator, COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542268
- Sponsor's protocol ID
- IBS-PTX
- Acronym
- IBS-PTX
- Status last verified
- Mar 2012
- First submitted
- 23 Sep 2011
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pentoxifylline on Tight Junctions of Intestinal Mucosa in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01542268
- Acronym / sponsor ID
- IBS-PTX / IBS-PTX
- Conditions
- Irritable Bowel Syndrome
- Keywords
- pentoxifylline, tight junction signalling, intestinal epithelial barrier, irritable bowel syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pentoxifylline | Active comparator | Drug: pentoxifylline |
| pentoxifylline placebo | Placebo comparator | Drug: pentoxifylline placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
- 3 months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive
- 6 months before colon biopsia, any patient cann´t recive radiotherapy or chemotherapy.
- Pentoxifilina Alergic Reactions
- Pregnants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pentoxifyllineAlso: APatients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months. | Drug | pentoxifylline |
| pentoxifylline placeboAlso: BPatients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months. | Drug | pentoxifylline placebo |
Primary outcome
Severity of abdominal pain
Time frame: 3 months from the first day of treatment
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. "
1 secondary outcome
Mucosal byopsies
Time frame: 3 months from the first day of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAURA RAMOS, MD principal investigator
COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pentoxifylline in people with Irritable Bowel Syndrome, run by Hospital Universitario de Canarias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LAURA RAMOS, MD (+34 922675557, laura7ramos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of abdominal pain (time frame: 3 months from the first day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.