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GABA-B Receptor Agonist

Baclofen for Rumination Syndrome

Phase 3

Recruiting

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will test if baclofen can help children with rumination syndrome. Participants take baclofen or placebo for 4 weeks and fill out surveys.

Who is the study for?

This trial is for children aged 4-18 with rumination syndrome, diagnosed according to Rome IV criteria and seen at the NCH GI clinic. It's not for those who can't take baclofen due to other health issues or medications, non-English speakers, or pregnant individuals.Check my eligibility

What is being tested?

The study tests if baclofen helps treat rumination syndrome in kids. Participants will randomly receive either baclofen or a placebo (a pill without active medicine) for four weeks and report their symptoms through surveys.See study design

What are the potential side effects?

Baclofen may cause side effects like sleepiness, weakness, dizziness, headache, seizures, nausea, low blood pressure and could potentially worsen underlying conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the investigators will assess this specific metric at the end of four weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the investigators will assess this specific metric at the end of four weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the investigators will assess this specific metric at the end of four weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vomiting once a week or less

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: BaclofenActive Control1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,453 Total Patients Enrolled

Media Library

Baclofen (GABA-B Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05975684 — Phase 3

Rumination Disorder Research Study Groups: Baclofen, Placebo

Rumination Disorder Clinical Trial 2023: Baclofen Highlights & Side Effects. Trial Name: NCT05975684 — Phase 3

Baclofen (GABA-B Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975684 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this research study limited to individuals under the age of 50?

"As specified in the trial's entry requirements, only children aged between 4 and 18 are eligible for enrollment."

Answered by AI

Are there any participation opportunities open to qualified candidates for this research project?

"Affirmative, clinicaltrials.gov indicates that this investigation is presently enrolling participants. It was initially announced on January 31st 2023 and most recently edited on July 27th 2023. The researchers are attempting to recruit 50 individuals from one medical centre."

Answered by AI

Has the Food and Drug Administration sanctioned Baclofen for medical use?

"Owing to the Phase 3 trial's established data related to efficacy and safety, Baclofen is assessed a score of 3 on our team at Power’s scale."

Answered by AI

Would I be eligible to join this research endeavor?

"To qualify for this clinical study, applicants must have rumination disorder and be between the ages of 4 to 18. This trial is targeting 50 candidates."

Answered by AI

What is the current capacity of this experiment?

"That is accurate. The information posted on clinicaltrials.gov confirms that this research project, which was initially advertised on January 31st 2023, is still recruiting participants. Approximately 50 individuals must be sourced from 1 medical centre for the trial to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Baclofen for Children With Rumination Syndrome

Peter Lu 2023. "Baclofen for Children With Rumination Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05975684.