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NCT05975684 · ClinicalTrials.gov registry record · Phase 3

Baclofen for Children With Rumination Syndrome

A Phase 3 study of Rumination Syndrome, sponsored by Nationwide Children's Hospital.

Completed
Registry status
Phase 3
Development phase
50
Enrollment target
1
Study location

NCT05975684: Completed Phase 3 study of Rumination Syndrome, sponsored by Nationwide Children's Hospital.

NCT05975684 is a Phase 3 study of Rumination Syndrome that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05975684, a Phase 3 study of Rumination Syndrome, has completed, sponsored by Nationwide Children's Hospital.

COMPLETED
Registry status
Phase 3
Development phase
50 participants
Enrollment target
1
Study location

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.

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Baclofen

Study Locations (1)

Ohio

  • Nationwide Children's Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-01-31
Est. Completion 2025-01-27
Phase Phase 3
Nationwide Children's Hospital

188 total trials

What the finished NCT05975684 record still lists

NCT05975684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Rumination Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05975684 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT05975684 about?

NCT05975684 is a clinical study titled "Baclofen for Children With Rumination Syndrome". 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 o...

What is the current status of trial NCT05975684?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2023-01-31. Estimated completion is 2025-01-27.

What conditions does trial NCT05975684 study?

This clinical trial studies the following conditions: Rumination Syndrome.

What interventions are being tested in trial NCT05975684?

The interventions under investigation include: Placebo (DRUG), Baclofen (DRUG).

Who is sponsoring clinical trial NCT05975684?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05975684 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05975684's enrollment target sits among peer trials

50 1844th of 2000 higher than 141 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05975684, the US trial registry maintained by the National Library of Medicine. NCT05975684 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.