Using ethosuximide and pentoxifylline to treat abdominal pain from IBS
A Comparative Study to Assess Safety and Effectiveness of Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome
This study is testing if the medications ethosuximide and pentoxifylline can help adults with irritable bowel syndrome feel less abdominal pain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT04217733 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of ethosuximide and pentoxifylline in alleviating abdominal pain associated with irritable bowel syndrome (IBS). Participants will be adults aged 18 and older who meet specific IBS criteria and have experienced significant pain in the week prior to enrollment. The study aims to determine if these medications can enhance current treatment options for IBS-related pain. The trial will involve a controlled intervention to assess pain relief and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with IBS who experience moderate to severe abdominal pain.
Not a fit: Patients with significant liver or renal disease, those with a history of severe depression, or individuals currently taking antiepileptic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from abdominal pain due to IBS.
How similar studies have performed: While the specific combination of ethosuximide and pentoxifylline has not been widely tested, similar approaches targeting IBS-related pain have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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,
Where this trial is running
Tanta
- Sherief Abd-Elsalam — Tanta, Egypt (Recruiting)
Study contacts
- Principal investigator: Mostafa Mahmoud Bahaa El dien, Msc — Clinical Pharmacy department
- Study coordinator: Sherief Abd-Elsalam, ass. prof.
- Email: sheriefabdelsalam@yahoo.com
- Phone: 00201147773440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.