Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
Status:
Withdrawn
Trial end date:
2012-04-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)