Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ARYx Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the efficacy of 3 oral dosing regimens of ATI 7505 compared to placebo in patients with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group who have had adequate relief of postprandial distress syndrome symptoms on at least 50% of the treatment days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | 2 Placebo tablets, TID, orally, 58 days |
|
| 2 | Experimental | 1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days |
|
| 3 | Experimental | 1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days |
|
| 4 | Experimental | 2 ATI 40mg tablets, TID, orally, 58 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 2 Placebo tablets, TID, orally, 58 days |
| |
| 20 mg ATI 7505 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS. | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ATI 7505 | 42 days | |
| Time to recurrence of the 2 primary PDS symptoms at day 42 | 42 days | |
| Effect of ATI 7505 treatment on quality of life indices |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruce C Yacyshyn, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Chino | California | 91710 | United States | ||
| Research Facility |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days |
|
| 40 mg ATI 7505 | Drug | 1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days |
|
| 80 mg ATI 7505 | Drug | 2 ATI 40mg tablets, TID, orally, 58 days |
|
| 42 days |
| Fresno |
| California |
| 93721 |
| United States |
| Research Facility | Los Angeles | California | 90015 | United States |
| Research Facility | Los Angeles | California | 90045 | United States |
| Research Facility | Mission Viejo | California | 92691 | United States |
| Research Facility | San Carlos | California | 94070 | United States |
| Research Facility | San Diego | California | 92108 | United States |
| Research Facility | Littleton | Colorado | 80120 | United States |
| Research Facility | Boynton Beach | Florida | 33426 | United States |
| Research Facility | DeLand | Florida | 32720 | United States |
| Research Facility | Hollywood | Florida | 33021 | United States |
| Research Facility | Jacksonville | Florida | 32256 | United States |
| Research Facility | Largo | Florida | 33777 | United States |
| Research Facility | Miami | Florida | 33156 | United States |
| Research Facility | New Port Richey | Florida | 34652 | United States |
| Research Facility | Orlando | Florida | 32806 | United States |
| Research Facility | Newnan | Georgia | 30263 | United States |
| Research Facility | Savannah | Georgia | 31405 | United States |
| Research Facility | Rockford | Illinois | 61107 | United States |
| Research Facility | Evansville | Indiana | 47714 | United States |
| Research Facility | Topeka | Kansas | 66606 | United States |
| Research Facility | Monroe | Louisiana | 71201 | United States |
| Research Facility | Detroit | Michigan | 48235 | United States |
| Research Facility | Brooklyn | New York | 11214 | United States |
| Research Facility | Great Neck | New York | 11021 | United States |
| Research Facility | Great Neck | New York | 11023 | United States |
| Research Facility | Lake Success | New York | 11042 | United States |
| Research Facility | Syracuse | New York | 13210 | United States |
| Research Facility | Fayetteville | North Carolina | 28304 | United States |
| Research Facility | Winston-Salem | North Carolina | 27103 | United States |
| Research Facility | Cincinnati | Ohio | 45242 | United States |
| Research Facility | Dayton | Ohio | 45440 | United States |
| Research Facility | Oklahoma City | Oklahoma | 73104 | United States |
| Research Facility | Oklahoma City | Oklahoma | 73112 | United States |
| Research Facility | Ashland | Oregon | 97520 | United States |
| Research Facility | Beaver Falls | Pennsylvania | 15010 | United States |
| Research Facility | Anderson | South Carolina | 29621 | United States |
| Research Facility | Charleston | South Carolina | 29414 | United States |
| Research Facility | Chattanooga | Tennessee | 37403 | United States |
| Research Facility | Chattanooga | Tennessee | 37404 | United States |
| Research Facility | Colleyville | Texas | 76034 | United States |
| Research Facility | Salt Lake City | Utah | 84124 | United States |
| Research Facility | Winchester | Virginia | 22601 | United States |
| Research Facility | Milwaukee | Wisconsin | 53209 | United States |
| Research Facility | Guelph | N1H 3R3 | Canada |
| Research Facility | Hamilton | L8N 3Z5 | Canada |
| Research Facility | Hamilton | L8N 4A6 | Canada |
| Research Facility | Lévis | G6V 3Z1 | Canada |
| Research Facility | Longueuil | J4N 1E1 | Canada |
| Research Facility | Montreal | H1T 2M4 | Canada |
| Research Facility | Ottawa | K1H 8L6 | Canada |
| Research Facility | Québec | G1L 3L5 | Canada |
| Research Facility | Québec | G1R 2J6 | Canada |
| Research Facility | Québec | G1S 4L8 | Canada |
| Research Facility | Saint-Charles-Borromée | J6E 6J2 | Canada |
| Research Facility | Toronto | M3N 2V7 | Canada |
| Research Facility | Birmingham | B9 5SS | United Kingdom |
| Research Facility | Cardiff | CF14 4XW | United Kingdom |
| Research Facility | Coventry | CV2 2DX | United Kingdom |
| Research Facility | Crewe | CW1 4QJ | United Kingdom |
| Research Facility | London | NW3 2QG | United Kingdom |
| Research Facility | Norwich | NR4 7UY | United Kingdom |
| Research Facility | Orpington | BR6 8ND | United Kingdom |
| Research Facility | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| C517618 | ATI 7505 |
Not provided
Not provided
Not provided