Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
Recruitment status was Recruiting
Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with CP and 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy|
- Symptom control [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Symptom frequency during the 2 weeks of placebo and baclofen administration.
- GERD control [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Frequency and duration of reflux episodes detected by MII during 24 hours of recording after two weeks of maximum dose.
Proportion of full-column and non-acid reflux episodes detected by MII during 24 hours after two weeks of maximum dose.
Frequency of TLESRs and reflux associated with TLESRs at half of the maximum dose, and after two weeks of maximum dose are administered
- side effects of baclofen [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]Incidence of side effects and rate of discontinuation of the study
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: baclofen||
The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.
Other Name: Lioresal
|Placebo Comparator: placebo||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386255
|Contact: Samuel Nurko, MD||617-355-6055||Samuel.Nurko@childrens.harvard.edu|
|United States, Massachusetts|
|Children's Hospital Boston||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Samuel Nurko, MD||Children's Hospital Boston|