IBS - Irritable Bowel SyndromePhase 3NCT04217733
Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome
A Phase 3 study testing pentoxyifylline, Mebeverine and ethosuximide in people with IBS - Irritable Bowel Syndrome, run by Tanta University at 1 site in Egypt.
Trial summary
Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- pentoxyifylline, Mebeverine and ethosuximide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 30 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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,
Show all 9Show fewer
- Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline.
- History or current severe depression (hospitalization, long-term antidepressant treatment)
- Psychotic disorders,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam, Ass. Prof., 00201009221243, sheriefabdelsalam@yahoo.com
About this study
Official title: A Comparative Study to Assess Safety and Effectiveness of Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome
Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome
Read the detailed description
Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome: Does this add to current treatment?
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- pentoxyifylline, Mebeverine, ethosuximide
- 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.
pentoxyifyllineDrug
Pentoxyifylline two times daily for 3 months
MebeverineDrug
Mebeverine 3 times for 3 months
ethosuximideDrug
ethosuximide 3 times for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Mebeverine | Active comparator | Mebeverine 3 times daily for 3 months Receives: Drug: Mebeverine |
| Ethosuximide | Experimental | Ethosuxemide 3 times daily for 3 months Receives: Drug: ethosuximide |
| Pentoxyifylline | Experimental | pentoxyifylline 2 times daily for 3 months Receives: Drug: pentoxyifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS
the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS
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 posted3 Jan 2020
- Study start1 Nov 2019
- Primary completion1 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Mostafa Mahmoud Bahaa El dien, Msc, Principal investigator, Clinical Pharmacy departmentSahar El-Haggar, Prof, Principal investigator, Clinical pharmacy Department- Tanta UniversitySahar Hegazy, Prof., Principal investigator, Clinical pharmacy Department- Tanta UniversitySherief Abd-Elsalam, Ass. Prof., Principal investigator, Tropical Medicine Department- Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217733
- Sponsor's protocol ID
- Sherief Protocol
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Haggar SM, Hegazy SK, Abd-Elsalam SM, Elkaeed EB, Al-Karmalawy AA, Bahaa MM. A Potential Role of Ethosuximide and Pentoxifylline in Relieving Abdominal Pain in Irritable Bowel Syndrome Patients Treated with Mebeverine: A Randomized, Double-Blind, Placebo-Controlled Trial. J Inflamm Res. 2022 Feb 19;15:1159-1172. doi: 10.2147/JIR.S346608. eCollection 2022.
PubMed 35221706El-Haggar SM, Hegazy SK, M Abd-Elsalam S, Bahaa MM. Open-label pilot study of ethosuximide as adjunctive therapy for relieving abdominal pain related to Irritable Bowel Syndrome. J Clin Pharm Ther. 2022 Mar;47(3):306-312. doi: 10.1111/jcpt.13556. Epub 2021 Nov 2.
PubMed 34726293
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Assess Safety and Effectiveness of Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04217733
- Acronym / sponsor ID
- Sherief Protocol
- Conditions
- IBS - Irritable Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Jan 2020 (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.
Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome
Detailed description
Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome: Does this add to current treatment?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mebeverine | Active comparator | Drug: MebeverineMebeverine 3 times daily for 3 months |
| Ethosuximide | Experimental | Drug: ethosuximideEthosuxemide 3 times daily for 3 months |
| Pentoxyifylline | Experimental | Drug: pentoxyifyllinepentoxyifylline 2 times daily for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Age ≥ 18 years,
Key exclusion criteria (9 listed)
- • Breastfeeding
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 |
|---|---|---|
| pentoxyifyllinePentoxyifylline two times daily for 3 months | Drug | Pentoxyifylline |
| MebeverineMebeverine 3 times for 3 months | Drug | Mebeverine |
| ethosuximideethosuximide 3 times for 3 months | Drug | Ethosuximide |
Primary outcome
Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS
Time frame: 6 months
the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Derived from this study: PubMed 35221706El-Haggar SM, Hegazy SK, Abd-Elsalam SM, Elkaeed EB, Al-Karmalawy AA, Bahaa MM. A Potential Role of Ethosuximide and Pentoxifylline in Relieving Abdominal Pain in Irritable Bowel Syndrome Patients Treated with Mebeverine: A Randomized, Double-Blind, Placebo-Controlled Trial. J Inflamm Res. 2022 Feb 19;15:1159-1172. doi: 10.2147/JIR.S346608. eCollection 2022.
- Derived from this study: PubMed 34726293El-Haggar SM, Hegazy SK, M Abd-Elsalam S, Bahaa MM. Open-label pilot study of ethosuximide as adjunctive therapy for relieving abdominal pain related to Irritable Bowel Syndrome. J Clin Pharm Ther. 2022 Mar;47(3):306-312. doi: 10.1111/jcpt.13556. Epub 2021 Nov 2.
- Individual participant dataSharing planned: No
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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.
Mostafa Mahmoud Bahaa El dien, Msc principal investigator
Clinical Pharmacy department
Sahar El-Haggar, Prof principal investigator
Clinical pharmacy Department- Tanta University
Sahar Hegazy, Prof. principal investigator
Clinical pharmacy Department- Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pentoxyifylline, Mebeverine and ethosuximide in people with IBS - Irritable Bowel Syndrome, 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Jan 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS (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 NCT04217733, which also lists 2 linked publications.
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 3 Jan 2020.