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New treatment option for Irritable Bowel Syndrome With Constipation
Official title Home Transcutaneous Electrical Acustimulation (TEA)
ClinicalTrials.gov ID: NCT05519683
What this study is testing
What is Lexapro?
Lexapro is an investigational medicine, being studied as a potential treatment for irritable bowel syndrome with constipation.
Also referred to as escitalopram.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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)
- Active use of prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotic (e.g., Seroquel, Risperdal), antidiarrheal, or frequent (\>2...
- Ongoing use of Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), or any other...
See the full eligibility 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 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.
- 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...
- 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)
- Active use of prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotic (e.g., Seroquel, Risperdal), antidiarrheal, or frequent (\>2 days/week) use of opioid or antispasmodic medication. Those who...
- Ongoing use of Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), or any other serotonin-active medications, including tricyclic antidepressants (TCAs)...
- Inability to avoid the following medications: tricyclic antidepressants, Monoamine Oxidase (MAO) inhibitors including, intravenous methylene blue, linezolid, and pimozide, as well as triptans, fentanyl, lithium...
- 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.
- Known QTc prolongation or receiving scheduled therapy with a medication associated with prolongation of QTc (screening to be completed at recruitment as detailed above).
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.