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Clinical trial

A Randomized Controlled Pilot Trial of Baclofen for Children With Rumination Syndrome

ID
Name
STUDY00002491
Description
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.
Trial arms
Trial start
2023-01-31
Estimated PCD
2023-12-01
Trial end
2024-04-01
Status
Recruiting
Phase
Early phase I
Treatment
Baclofen
0.5 mg/kg/day up to 15 mg/day divided three times a day for 4 weeks
Arms:
Baclofen
Placebo
Placebo three times a day for 4 weeks
Arms:
Placebo
Size
50
Primary endpoint
Vomiting once a week or less
The investigators will assess this specific metric at the end of four weeks.
Eligibility criteria
Inclusion Criteria: * Children 4-18 years of age who meets Rome IV diagnostic criteria for rumination syndrome and are see at NCH GI clinic Exclusion Criteria: * Patients who have contraindications to baclofen due to medical history and/or current medications * Patients who are non- English speaking * Patients who are pregnant
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel groups of (a) baclofen or (b) placebo control', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-09-21

1 organization

2 products

1 indication

Organization
Nationwide Children's Hospital
Product
Baclofen
Indication
Rumination Syndrome
Product
Placebo