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To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XP19986 SR3, 20 mg QD | Experimental | XP19986, 20 mg QD for approximately 32 days |
|
| XP19986 SR3, 40 mg QD | Experimental | XP19986, 40 mg QD for approximately 32 days |
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| XP19986 SR3, 60 mg QD | Experimental | XP19986, 60 mg QD for approximately 32 days |
|
| XP19986 SR3, 30 mg BID | Experimental | XP19986, 30 mg BID for approximately 32 days |
|
| Placebo | Placebo Comparator | Placebo for approximately 32 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XP19986 SR3, 20 mg QD | Drug | XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of heartburn events over the treatment period | 4-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms | 4-weeks |
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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 |
|---|---|---|---|---|---|---|
| MDS Pharma Services | Irvine | California | 92618 | United States |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C543531 | arbaclofen placarbil |
| C494814 | BID protein, human |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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|
| XP19986 SR3, 40 mg QD | Drug | XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods. |
|
|
| XP19986 SR3, 60 mg QD | Drug | XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods. |
|
|
| XP19986 SR3, 30 mg BID | Drug | XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods. |
|
|
| Placebo | Drug | Placebo tablet taken orally for approximately 32 days with titration and taper periods. |
|
|
| D004066 | Digestive System Diseases |