NCT01386255

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy
• GERD

Interventions

Type	Name	Description
DRUG	Baclofen	The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.
DRUG	placebo	placebo. No other names

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-04-01
• Completion: 2012-04-30
• First posted: 2011-07-01
• Last updated: 2017-08-29

Locations

1 site across 1 country: United States