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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK077678-01 | U.S. NIH Grant/Contract | View source |
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No participants were enrolled
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| baclofen | Active Comparator | Baclofen suspension |
|
| placebo | Placebo Comparator | Identical palcebo suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug | The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom control | Symptom frequency during the 2 weeks of placebo and baclofen administration. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Nurko, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| placebo | Drug | placebo. No other names |
|
| side effects of baclofen | Incidence of side effects and rate of discontinuation of the study | 3 weeks |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |