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

Sponsor
Boston Children's Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01386255
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
0
Enrollment
1
Location
2
Arms
37
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Apr 30, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: baclofen

Baclofen suspension

Drug: Baclofen
The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.
Other Names:
  • Lioresal

    		•
    Placebo Comparator: placebo

    Identical palcebo suspension

    Drug: placebo
    placebo. No other names

    Outcome Measures

    Primary Outcome Measures

    1. Symptom control [3 weeks]

      Symptom frequency during the 2 weeks of placebo and baclofen administration.

    Secondary Outcome Measures

    1. GERD control [3 weeks]

      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

    2. side effects of baclofen [3 weeks]

      Incidence of side effects and rate of discontinuation of the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Boston Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Boston Children's Hospital
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Samuel Nurko, MD, Boston Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samuel Nurko, Attending Physician; Director, Center for Motility and Functional Gastrointestinal Disorders, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01386255
    Other Study ID Numbers:
    • Baclofen-07-02-0077
    • 1R21DK077678-01
    First Posted:
    Jul 1, 2011
    Last Update Posted:
    Aug 29, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by Samuel Nurko, Attending Physician; Director, Center for Motility and Functional Gastrointestinal Disorders, Boston Children's Hospital
    GERD
    Additional relevant MeSH terms:
    Cerebral Palsy
    Baclofen

    Study Results

    No Results Posted as of Aug 29, 2017