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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Boston Children’s Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Boston Children’s Hospital
ClinicalTrials.gov Identifier:
NCT01386255
First received: June 29, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose
Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with CP and 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 Intervention Phase
Cerebral Palsy
GERD
Drug: Baclofen
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:
  • Symptom control [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Symptom frequency during the 2 weeks of placebo and baclofen administration.


Secondary Outcome Measures:
  • GERD control [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    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


  • side effects of baclofen [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Incidence of side effects and rate of discontinuation of the study


Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: baclofen Drug: Baclofen
The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.
Other Name: Lioresal
Placebo Comparator: placebo Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386255

Contacts
Contact: Samuel Nurko, MD 617-355-6055 Samuel.Nurko@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
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
  More Information

Responsible Party: Samuel Nurko, MD/Director, Center for Motility and Functional Gastrointestinal Disorders, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01386255     History of Changes
Other Study ID Numbers: Baclofen-07-02-0077  1R21DK077678-01 
Study First Received: June 29, 2011
Last Updated: June 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Children’s Hospital:
GERD

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 26, 2016