Baclofen for Children With Rumination Syndrome

NCT05975684 | Completed Phase 3 FDA Drug

• 1 other identifier: STUDY00002491
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Vomiting once a week or less

  Percentage of participants in each group who are vomiting once a week or less. This will be evaluated using a rumination severity survey.

  The investigators will assess this specific metric at the end of four weeks.

Study Arms (2)

Baclofen

ACTIVE COMPARATOR

Baclofen 0.5 mg/kg/day up to 15 mg/day divided three times a day in liquid formulation for 4 weeks.

Drug: Baclofen

Placebo

PLACEBO COMPARATOR

Matching placebo three times a day in liquid formulation for 4 weeks.

Drug: Placebo

Interventions

Baclofen DRUG

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

Baclofen

Placebo DRUG

Placebo three times a day for 4 weeks

Placebo

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children 4-18 years of age who meets Rome IV diagnostic criteria for rumination syndrome and are see at NCH GI clinic

You may not qualify if:

• Patients who have contraindications to baclofen due to medical history and/or current medications
• Patients who are non- English speaking
• Patients who are pregnant

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 73205, United States

Location

MeSH Terms

Conditions

Rumination Syndrome

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be randomized into one of two parallel groups in 1:1 ratio. The specific details of randomization sequence will be managed by investigational pharmacy. The participant, care provider, and research team are blinded to randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics

Model Details: Parallel groups of (a) baclofen or (b) placebo control

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: January 31, 2023
• Primary Completion: July 31, 2024
• Study Completion: January 27, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)