Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title: Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• GERD
• Paralysis

• NCT number: NCT01386255
• Study type: Interventional
• Source: Boston Children’s Hospital
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 2009
• Completion date: April 30, 2012