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The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil (XP19986) compared to placebo in patients with gastroesophageal reflux disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XP19986 CR | Experimental | On either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of XP19986 10, 20, 40 or 60 mg. |
|
| Placebo for XP19986 CR | Placebo Comparator | On either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XP19986 CR | Drug |
|
| |
| Placebo for XP19986 CR |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy assessment endpoint of this study was the total number of reflux episodes (acid and non-acid) comparing study drug to placebo | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reflux episodes (acid and non-acid) during each treatment period at various time intervals, dose/exposure to reflux rate relationship, acid reflux events, non-acid reflux events, and GERD symptoms. | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Huff, M.D. | XenoPort, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | California | 94305 | United States | |||
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| Drug |
|
|
| Charleston |
| South Carolina |
| 29425 |
| United States |
| Tacoma | Washington | 98403 | United States |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C050528 | Eudragit RS |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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