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Baclofen for Children With Rumination Syndrome

NCT05975684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-06

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about baclofen in pediatric patients with rumination syndrome. The main question it aims to answer is whether baclofen is effective in treating children with rumination syndrome. Participants will be asked to take baclofen or placebo for 4 weeks and fill out surveys regarding symptoms.

Conditions

  • Rumination Syndrome

Interventions

DRUG

Baclofen

0.5 mg/kg/day up to 15 mg/day divided three times a day for 4 weeks

DRUG

Placebo

Placebo three times a day for 4 weeks

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-07-31
Completion
2025-01-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975684 on ClinicalTrials.gov