Home Transcutaneous Electrical Acustimulation (TEA)

Recruiting Phase 2 Phase 3 Interventional Study
Irritable Bowel Syndrome With Constipation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
University of Michigan · Other
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About This Trial

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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 …
Contacts

Colin Burnett

734-647-2806

bucolin@med.umich.edu

CONTACT