Study Stopped
No participants were enrolled
Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR). Furthermore, in patients with CP, surgical options are fraught with serious complications and long-term morbidity. Because the available treatment options for children with CP and intractable GERD are limited, new therapies are urgently needed. Baclofen, which has been shown in animals and humans to decrease TLESRs, may be a good alternative for the treatment of children with CP with intractable GERD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2012
CompletedAugust 29, 2017
August 1, 2017
3 years
June 29, 2011
August 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom control
Symptom frequency during the 2 weeks of placebo and baclofen administration.
3 weeks
Secondary Outcomes (2)
GERD control
3 weeks
side effects of baclofen
3 weeks
Study Arms (2)
baclofen
ACTIVE COMPARATORBaclofen suspension
placebo
PLACEBO COMPARATORIdentical palcebo suspension
Interventions
Eligibility Criteria
You may qualify if:
- years old
- Diagnosis of Cerebral Palsy
- Symptoms of GERD for at least 3 months
- At least 8 weeks on BID therapy with a PPI at a therapeutic dose at time of enrollment
- Normal upper gastrointestinal barium contrast study (UGI)
- Have a g-tube that is used for more than 75% of calories and a stable feeding schedule for at least 2 weeks
- If seizures are present, they need to be controlled and on stable medications for 4 weeks
You may not qualify if:
- Underlying electrolyte disturbance
- History of Nissen fundoplication
- Renal insufficiency
- Currently receiving baclofen
- Baclofen allergy
- Uncontrolled seizure disorder
- Lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Nurko, MD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician; Director, Center for Motility and Functional Gastrointestinal Disorders
Study Record Dates
First Submitted
June 29, 2011
First Posted
July 1, 2011
Study Start
April 1, 2009
Primary Completion
April 1, 2012
Study Completion
April 30, 2012
Last Updated
August 29, 2017
Record last verified: 2017-08