Inflammatory Bowel DiseasesPhase 2NCT05558761
Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis
A Phase 2 study testing Pentoxifylline 400 MG in people with Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
Trial summary
The exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Pentoxifylline 400 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2022to 20 Apr 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception
Who cannot join
- Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Known allergy to the studied medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With Mesalamine
The exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Due to genetic, immune, and environmental factors, UC is highly dependent on cellular immune reactions and exaggerated inflammatory responses. The release of several cytokines, kinins, leukotrienes, platelet-activating factor (PAF), and reactive oxygen species is connected to immunological activity (ROS). Additionally, many of the cytokines will start an acute phase response, making the inflammation worse.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Pentoxifylline 400 MG
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline 400 MGDrug
Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics. PTX exerts anti-inflammatory effects by inhibiting phosphodiesterase and activating the adenosine 2 receptor
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | this group will take mesalamine 1 g three times daily |
| Pentoxifylline group | Active comparator | his group will take mesalamine 1 g three times daily plus pentoxifylline 400 mg two times daily Receives: Drug: Pentoxifylline 400 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in health related quality of life
Short Form 36 Health Survey (SF-36) will assess the quality of life. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Measured: 6 months
Secondary outcomes (1)
changes in the level of measured biomarkers.
changes in the level of measured biomarkers through assessment serum level of TNF- alpha, serum IL-10, and gene expression of zonula occuldin-1(ZO-1).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start10 Oct 2022
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
- Investigators
- Mostafa M Bahaa, PhD, Principal investigator, Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558761
- Sponsor's protocol ID
- 3455
- Status last verified
- Aug 2025
- First submitted
- 25 Sep 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bahaa MM, Hegazy SK, Maher MM, Bahgat MM, El-Haggar SM. Pentoxifylline in patients with ulcerative colitis treated with mesalamine by modulation of IL-6/STAT3, ZO-1, and S1P pathways: a randomized controlled double-blinded study. Inflammopharmacology. 2024 Oct;32(5):3247-3258. doi: 10.1007/s10787-024-01560-6. Epub 2024 Aug 27.
PubMed 39192162
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With Mesalamine
- ClinicalTrials.gov ID
- NCT05558761
- Acronym / sponsor ID
- 3455
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 28 Sep 2022 (actual)
- 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 exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Due to genetic, immune, and environmental factors, UC is highly dependent on cellular immune reactions and exaggerated inflammatory responses. The release of several cytokines, kinins, leukotrienes, platelet-activating factor (PAF), and reactive oxygen species is connected to immunological activity (ROS). Additionally, many of the cytokines will start an acute phase response, making the inflammation worse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –this group will take mesalamine 1 g three times daily |
| Pentoxifylline group | Active comparator | Drug: Pentoxifylline 400 MGhis group will take mesalamine 1 g three times daily plus pentoxifylline 400 mg two times daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception
Key exclusion criteria (1 listed)
- Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Known allergy to the studied medications
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 |
|---|---|---|
| Pentoxifylline 400 MGPentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics. PTX exerts anti-inflammatory effects by inhibiting phosphodiesterase and activating the adenosine 2 receptor | Drug | Pentoxifylline group |
Primary outcome
Improvement in health related quality of life
Time frame: 6 months
Short Form 36 Health Survey (SF-36) will assess the quality of life. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
1 secondary outcome
changes in the level of measured biomarkers.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 39192162Bahaa MM, Hegazy SK, Maher MM, Bahgat MM, El-Haggar SM. Pentoxifylline in patients with ulcerative colitis treated with mesalamine by modulation of IL-6/STAT3, ZO-1, and S1P pathways: a randomized controlled double-blinded study. Inflammopharmacology. 2024 Oct;32(5):3247-3258. doi: 10.1007/s10787-024-01560-6. Epub 2024 Aug 27.
Related trials for Inflammatory Bowel Diseases
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 1
A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
Colitis, Ulcerative
Not yet recruitingPhase 2
Oral N-acetylglucosamine in Crohn's Disease
Crohns Disease
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.
Mostafa M Bahaa, PhD principal investigator
Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentoxifylline 400 MG in people with Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Aug 2025. 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 Egypt. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in health related quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558761, which also lists 1 linked publication.
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 11 Aug 2025.