Phase 3 Irritable Bowel Syndrome Trial, Recruiting NCT05519683 Sponsor: University of Michigan Condition: Irritable Bowel Syndrome
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Phase 3 Irritable Bowel Syndrome Trial, Recruiting

NCT05519683
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Irritable Bowel Syndrome with Constipation (IBS-C) and are currently experiencing symptoms.
  • Your abdominal pain reaches a significant level of severity during a lead-in monitoring period before the trial begins (the exact level is defined by the study protocol — confirm with trial site).
  • You have had symptoms on at least one day per week for the last 3 months, and your symptoms first started at least 6 months before your diagnosis.
  • Your abdominal pain is not being adequately controlled at the time you are assessed for the trial.

Who may not be able to join:

  • You have another active condition that could also cause abdominal pain, such as inflammatory bowel disease, diabetes, or an unstable thyroid condition.
  • You are pregnant, planning to become pregnant, or currently breastfeeding. (A pregnancy test will be done at the first visit, and a positive result would mean you cannot join.)
  • You have any other condition that, in the doctor's judgment, might make it difficult for you to follow the study requirements or complete it (confirm with trial site).
  • You have had abdominal surgery in the past, other than having your gallbladder or appendix removed.
  • You are currently taking certain medications, including prucalopride, domperidone, alosetron, tegaserod, warfarin, certain antipsychotic medications, anti-diarrhoea medications, or you use opioid or antispasmodic medications more than 2 days per week. Regular use of anti-inflammatory painkillers (such as ibuprofen or naproxen) would also exclude you.
  • You are currently taking antidepressants or other medications that affect serotonin levels in the body, including SSRIs (such as escitalopram), SNRIs, or tricyclic antidepressants.
  • You are unable to avoid a specific list of medications during the trial, including certain antidepressants (tricyclics and MAO inhibitors), migraine medications (triptans), fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort. Note that MAO inhibitors must not be used within 14 days of starting or stopping the study medication.
  • You have a known allergy or sensitivity to the medications escitalopram or citalopram, or any of their ingredients.
  • You have a known allergy to the adhesive patches used for heart monitoring (ECG electrodes).
  • You have been diagnosed with angle-closure glaucoma, bipolar disorder, a history of seizures, a previous suicide attempt, or known suicidal thoughts.
  • You have a known heart condition involving a prolonged QTc interval, or you regularly take a medication known to prolong QTc (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Borko Nojkov, MD, University of Michigan

Phone: 734-647-2806

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
2 November 2022
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey; Change in global abdominal pain

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov