NCT04217733 Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome
| NCT ID | NCT04217733 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tanta University |
| Condition | IBS - Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-11-01 |
| Primary Completion | 2030-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2019-11-01 with a primary completion date of 2030-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome
Eligibility Criteria
Inclusion Criteria: * • Age ≥ 18 years, * Man and Women, Negative pregnancy test and effective contraception, * IBS defined by the Rome criteria IV * During the previous seven days the inclusion visit, average numeric rating scale (NRS) pain ≥ 4. * IBS Treatment stable for 1 month Exclusion Criteria: * • Breastfeeding * Diabetic patients * Significant liver function abnormalities (transaminases\> 3N, cholestasis) and moderate renal disease (MDRD \<60 ml / min) * Addiction to alcohol and / or drugs, * Antiepileptic drugs taken (epilepsy or chronic pain) * Chronic pain of greater intensity than that related to IBS, * Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline. * History or current severe depression (hospitalization, long-term antidepressant treatment) * Psychotic disorders,
Contact & Investigator
Mostafa Mahmoud Bahaa El dien, Msc
PRINCIPAL INVESTIGATOR
Clinical Pharmacy department
Frequently Asked Questions
Who can join the NCT04217733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IBS - Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04217733 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT04217733 currently recruiting?
Yes, NCT04217733 is actively recruiting participants. Contact the research team at sheriefabdelsalam@yahoo.com for enrollment information.
Where is the NCT04217733 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT04217733 clinical trial?
NCT04217733 is sponsored by Tanta University. The principal investigator is Mostafa Mahmoud Bahaa El dien, Msc at Clinical Pharmacy department. The trial plans to enroll 60 participants.