Clinical trial NCT01386255: Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
Official title: Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cerebral Palsy
GERD
Keywords: GERD
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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).

This is a placebo controlled trial of baclofen for the treatment of GERD in children with CP.

Eligibility criteria: Inclusion Criteria:

* 3-18 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

Exclusion Criteria:

* Underlying electrolyte disturbance
* History of Nissen fundoplication
* Renal insufficiency
* Currently receiving baclofen
* Baclofen allergy
* Uncontrolled seizure disorder
* Lack of informed consent

Primary outcomes:
measure: Symptom control
timeFrame: 3 weeks
Secondary outcomes:
measure: GERD control
timeFrame: 3 weeks
measure: side effects of baclofen
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Samuel Nurko, MD
role: PRINCIPAL_INVESTIGATOR
References: