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NCT05519683 · ClinicalTrials.gov registry record · Phase 2
Home Transcutaneous Electrical Acustimulation (TEA)
A Phase 2 study of Irritable Bowel Syndrome With Constipation, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT05519683: Recruiting Phase 2 study of Irritable Bowel Syndrome With Constipation, sponsored by University of Michigan.
NCT05519683 is a Phase 2 study of Irritable Bowel Syndrome With Constipation that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 160 participants, roughly in line with the 159-participant average among 3 other Irritable Bowel Syndrome With Constipation trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05519683, a Phase 2 study of Irritable Bowel Syndrome With Constipation, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Participants will complete a daily VAS survey to measure daily discomfort. There are four metrics measured in this form, abdominal pain, abdominal bloating, abdominal fullness, and abdominal cramping. These are scored on a line from 0 to 10, with 0 being the lowest (no pain) and 10 being the highest (worst imaginable pain) These scores will be totaled each day and compared from day 0 to day 98, or the end of week 14.
Conditions Studied
Interventions
- DEVICE TEA
- DRUG Lexapro
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT05519683 shows while recruiting
NCT05519683 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 159-participant average among 3 other Irritable Bowel Syndrome With Constipation trials with a reported enrollment target.
The record links to 1 condition, with Irritable Bowel Syndrome With Constipation appearing as the primary indexed condition, and to 2 interventions - of which TEA is the first listed.
NCT05519683 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05519683 about?
NCT05519683 is a clinical study titled "Home Transcutaneous Electrical Acustimulation (TEA)". 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.
What is the current status of trial NCT05519683?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2022-11-02. Estimated completion is 2026-09.
What conditions does trial NCT05519683 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome With Constipation.
What interventions are being tested in trial NCT05519683?
The interventions under investigation include: TEA (DEVICE), Lexapro (DRUG).
Who is sponsoring clinical trial NCT05519683?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05519683 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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