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.
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 …
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