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The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo BID | Placebo Comparator | Placebo once in the morning and once in the evening. |
|
| IW-9179 QD AM + Placebo QD PM | Experimental | IW-9179 once in the morning and placebo once in the evening. |
|
| Placebo QD AM + IW-9179 QD PM | Experimental | Placebo once in the morning and IW-9179 once in the evening. |
|
| IW-9179 BID | Experimental | IW-9179 once in the morning and once in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IW-9179 | Drug |
| ||
| Matching Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms | Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Investigational Site | Birmingham | Alabama | 35203 | United States | ||
| Ironwood Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29079987 | Derived | Ervin CM, Reasner DS, Hanlon JT, Fehnel SE. Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews. Adv Ther. 2017 Dec;34(12):2680-2692. doi: 10.1007/s12325-017-0632-6. Epub 2017 Oct 27. |
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| Drug |
|
| Dothan |
| Alabama |
| 36305 |
| United States |
| Ironwood Investigational Site | Tucson | Arizona | 85710 | United States |
| Ironwood Investigational Site | North Little Rock | Arkansas | 72117 | United States |
| Ironwood Investigational Site | Chula Vista | California | 91910 | United States |
| Ironwood Investigational Site | Los Angeles | California | 90036 | United States |
| Ironwood Investigational Site | Ventura | California | 93003 | United States |
| Ironwood Investigational Site | Miami | Florida | 33122 | United States |
| Ironwood Investigational Site | Tampa | Florida | 33607 | United States |
| Ironwood Investigational Site | Urbana | Illinois | 61801 | United States |
| Ironwood Investigational Site | Bastrop | Louisiana | 71220 | United States |
| Ironwood Investigational Site | Chesterfield | Michigan | 48047 | United States |
| Ironwood Investigational Site | Rochester | Minnesota | 55905 | United States |
| Ironwood Investigational Site | Great Neck | New York | 11023 | United States |
| Ironwood Investigational Site | New York | New York | 10018 | United States |
| Ironwood Investigational Site | Poughkeepsie | New York | 12601 | United States |
| Ironwood Investigational Site | Greensboro | North Carolina | 27410 | United States |
| Ironwood Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Ironwood Investigational Site | Chattanooga | Tennessee | 37421 | United States |
| Ironwood Investigational Site | Houston | Texas | 77015 | United States |
| Ironwood Investigational Site | Webster | Texas | 77598 | United States |
| Ironwood Investigational Site | Ogden | Utah | 84405 | United States |