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

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ClinicalTrials.gov Identifier: NCT01386255
Recruitment Status : Withdrawn (No participants were enrolled)
First Posted : July 1, 2011
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Samuel Nurko, Boston Children’s Hospital

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
Cerebral Palsy GERD Drug: Baclofen Drug: placebo 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 Type : Interventional  (Clinical Trial)
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 : April 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 30, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen
U.S. FDA Resources

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 Name: Lioresal
Placebo Comparator: placebo
Identical palcebo suspension
Drug: placebo
placebo. No other names



Primary Outcome Measures :
  1. Symptom control [ Time Frame: 3 weeks ]
    Symptom frequency during the 2 weeks of placebo and baclofen administration.


Secondary Outcome Measures :
  1. GERD control [ Time Frame: 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 [ Time Frame: 3 weeks ]
    Incidence of side effects and rate of discontinuation of the study



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386255


Locations
United States, Massachusetts
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

Responsible Party: Samuel Nurko, Attending Physician; Director, Center for Motility and Functional Gastrointestinal Disorders, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01386255     History of Changes
Other Study ID Numbers: Baclofen-07-02-0077
1R21DK077678-01 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Samuel Nurko, 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