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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01386255
• Other study ID #: Baclofen-07-02-0077
• Secondary ID: 1R21DK077678-01
• Status: Withdrawn
• Phase: Phase 4
• First received: June 29, 2011
• Last updated: August 26, 2017
• Start date: April 2009
• Est. completion date: April 30, 2012

Study information

• Verified date: August 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• GERD
• Paralysis

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom control	Symptom frequency during the 2 weeks of placebo and baclofen administration.	3 weeks
Secondary	GERD control	Frequency and duration of reflux episodes detected by MII during 24 hours of recording after two weeks of maximum dose.; Proportion of full-column and non-acid reflux episodes detected by MII during 24 hours after two weeks of maximum dose.; Frequency of TLESRs and reflux associated with TLESRs at half of the maximum dose, and after two weeks of maximum dose are administered	3 weeks
Secondary	side effects of baclofen	Incidence of side effects and rate of discontinuation of the study	3 weeks