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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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

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Cerebral Palsy GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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baclofen

Baclofen suspension

Group Type ACTIVE_COMPARATOR

Baclofen

Intervention Type DRUG

The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.

placebo

Identical palcebo suspension

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo. No other names

Interventions

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Baclofen

The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.

Intervention Type DRUG

placebo

placebo. No other names

Intervention Type DRUG

Other Intervention Names

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Lioresal

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No