RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing Lexapro for Irritable Bowel Syndrome With Constipation

This study will assess the how well it works of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.

Official registry: https://clinicaltrials.gov/study/NCT05519683 · University of Michigan · enrollment listed as 160

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TEA, or Lexapro. The registry lists allocation as randomized. This study will assess the how well it works of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.

They plan to enroll about 160 people at Ann Arbor. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)

Interventions: TEA, Lexapro

Primary outcome (registry wording): Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey

Who it is for (from inclusion criteria)

Ages 18 Years to any
Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)
Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period
Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis
Abdominal pain is not adequately relieved at the time of screening and the time of randomization

Who the registry excludes

Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease
Pregnancy, plans to become pregnant, or lactation. Any potential patient of child-bearing potential will complete a pregnancy test at Visit 1 and if the test is positive that individual will be excluded from future participation
Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
A history of abdominal surgery (other than cholecystectomy or appendectomy)
Known hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations
Known allergy to adhesive Electrocardiogram (ECG) electrodes
Known angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts

Public study contact (from the registry)

Colin Burnett

734-647-2806

bucolin@med.umich.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

University of Michigan — Ann Arbor, Michigan (recruiting)

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FAQ about this NCT record

Is NCT05519683 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05519683?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05519683?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary