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

Boston Children's Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Cerebral Palsy; GERD

Treatments: Drug: placebo; Drug: Baclofen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01386255

1R21DK077678-01 (U.S. NIH Grant/Contract)

Baclofen-07-02-0077

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 3-18 years old
• Diagnosis of Cerebral Palsy
• Symptoms of GERD for at least 3 months
• At least 8 weeks on BID therapy with a PPI at a therapeutic dose at time of enrollment
• Normal upper gastrointestinal barium contrast study (UGI)
• Have a g-tube that is used for more than 75% of calories and a stable feeding schedule for at least 2 weeks
• If seizures are present, they need to be controlled and on stable medications for 4 weeks

Exclusion criteria

• Underlying electrolyte disturbance
• History of Nissen fundoplication
• Renal insufficiency
• Currently receiving baclofen
• Baclofen allergy
• Uncontrolled seizure disorder
• Lack of informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

baclofen

Active Comparator group

Description:

Baclofen suspension

Treatment:

Drug: Baclofen

placebo

Placebo Comparator group

Description:

Identical palcebo suspension

Treatment:

Drug: placebo