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NOT YET RECRUITING
NCT07556718
PHASE2

Amitriptyline for IBS-like Symptoms in Quiescent Crohn's Disease

Sponsor: University of Michigan

View on ClinicalTrials.gov

Summary

Many individuals with Crohn's disease continue to experience abdominal pain, bloating, or bowel habit changes even when their inflammation is controlled. Amitriptyline is a medication commonly used at low doses to treat irritable bowel syndrome (IBS) and abdominal pain. This study will assess whether amitriptyline is safe and reduces those ongoing GI symptoms in adults with Crohn's disease in remission.

Official title: Amitriptyline for IBS-like Symptoms in Quiescent Crohn's Disease: A Multicenter Randomized Placebo-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04

Completion Date

2029-12

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

DRUG

Amitriptyline

Amitriptyline will be administered orally once daily. It will be dispensed in capsules or tablets that are visually identical to placebo. Self-titration schedule beginning at 10 mg and increasing to a maximum of 50 mg over the first six weeks, as tolerated. Participants will continue their maximum tolerated dose through Week 24.

DRUG

Placebo

Placebo capsules or tablets will be visually indistinguishable from amitriptyline to maintain participant and investigator blinding. Self-titration schedule beginning at 10 mg and increasing to a maximum of 50 mg over the first six weeks, as tolerated. Participants will continue their maximum tolerated placebo dose through Week 24.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States