Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
|ClinicalTrials.gov Identifier: NCT01386255|
Recruitment Status : Withdrawn (No participants were enrolled)
First Posted : July 1, 2011
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy GERD||Drug: Baclofen Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 30, 2012|
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
Identical palcebo suspension
placebo. No other names
- Symptom control [ Time Frame: 3 weeks ]Symptom frequency during the 2 weeks of placebo and baclofen administration.
- GERD control [ Time Frame: 3 weeks ]
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 ]Incidence of side effects and rate of discontinuation of the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386255
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Samuel Nurko, MD||Boston Children’s Hospital|