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The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm 1 | Experimental | ONO-2952 low dose every day for 4 weeks |
|
| Experimental Arm 2 | Experimental | ONO-2952 high dose every day for 4 weeks |
|
| Placebo Arm | Placebo Comparator | ONO-2952 Matching Placebo every day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-2952 | Drug |
| ||
| ONO-2952 Matching Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IBS related symptoms and quality of life (QoL) by questionaire assessments | 4 weeks | |
| Safety assessed through adverse events and clinical laboratory values | 4 weeks |
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Inclusion Criteria:
Female 18-65 years of age (inclusive)
Diagnosed with IBS based on the following criteria (Rome III criteria):
Symptom onset at least 6 months prior to diagnosis, and
Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston Clinical Site | Anniston | Alabama | 36207 | United States | ||
| Goodyear Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27910150 | Derived | Whitehead WE, Duffy K, Sharpe J, Nabata T, Bruce M. Randomised clinical trial: exploratory phase 2 study of ONO-2952 in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2017 Jan;45(1):14-26. doi: 10.1111/apt.13839. Epub 2016 Nov 7. |
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| Drug |
|
| Goodyear |
| Arizona |
| 85351 |
| United States |
| Tucson Clinical Site | Tucson | Arizona | 85712 | United States |
| North Little Rock Clinical Site | North Little Rock | Arkansas | 72120 | United States |
| Carlsbad Clinical Site | Carlsbad | California | 92008 | United States |
| San Diego Clinical Site | San Diego | California | 92114 | United States |
| Boynton Beach Clinical Site | Boynton Beach | Florida | 33426 | United States |
| Clearwater Clinical Site | Clearwater | Florida | 33756 | United States |
| Deland Clinical Site | DeLand | Florida | 32720 | United States |
| Hialeah Clinical Site | Hialeah | Florida | 33012 | United States |
| Lauderdale Lakes Clinical Site | Lauderdale Lakes | Florida | 33319 | United States |
| Orlando Clinical Site | Orlando | Florida | 32806 | United States |
| Port Orange Clinical Site | Port Orange | Florida | 32129 | United States |
| South Miami Clinical Site | South Miami | Florida | 33143 | United States |
| St. Petersburg Clinical Site | St. Petersburg | Florida | 33709 | United States |
| Tampa Clinical Site | Tampa | Florida | 33606 | United States |
| West Palm Clinical Site | West Palm | Florida | 33409 | United States |
| Oak Lawn Clinical Site | Oak Lawn | Illinois | 60453 | United States |
| Wichita Clinical Site | Wichita | Kansas | 67203 | United States |
| New Orleans Clinical Site | New Orleans | Louisiana | 70115 | United States |
| Chesterfield Clincial Site | Chesterfield | Michigan | 48047 | United States |
| Billings Clinical Site | Billings | Montana | 59102 | United States |
| Reno Clinical Site | Reno | Nevada | 89511 | United States |
| Lebanon Clinical Site | Lebanon | New Hampshire | 03756 | United States |
| Albuquerque Clinical Site | Albuquerque | New Mexico | 87102 | United States |
| Great Neck Clinical Site | Great Neck | New York | 11023 | United States |
| Cary Clinical Site | Cary | North Carolina | 27518 | United States |
| Highpoint Clinical Site | Highpoint | North Carolina | 27262 | United States |
| Raleigh Clinical Site | Raleigh | North Carolina | 27612 | United States |
| Winston-Salem Clinical Site | Winston-Salem | North Carolina | 27103 | United States |
| Akron Clinical Site | Akron | Ohio | 44311 | United States |
| Columbus Clinical Site | Columbus | Ohio | 43212 | United States |
| Dayton Clinical Site | Dayton | Ohio | 45432 | United States |
| Groveport Clinical Site | Groveport | Ohio | 43125 | United States |
| Mentor Clinical Site | Mentor | Ohio | 44060 | United States |
| Norman Clinical Site | Norman | Oklahoma | 73069 | United States |
| Lansdale Clinical Site | Landsdale | Pennsylvania | 19446 | United States |
| Greer Clinical Site | Greer | South Carolina | 29650 | United States |
| Mt. Pleasant Clinical Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Chattanooga Clinical Site | Chattanooga | Tennessee | 37421 | United States |
| Germantown Clinical Site | Germantown | Tennessee | 38138 | United States |
| Pasadena Clinical Site | Pasadena | Texas | 77505 | United States |
| Plano Clinial Site | Plano | Texas | 75075 | United States |
| San Antonio Clinical Site | San Antonio | Texas | 78229 | United States |
| Logan Clinical Site | Logan | Utah | 84341 | United States |
| Ogden Clinical Site | Ogden | Utah | 84405 | United States |
| Salt Lake City Clinical Site | Salt Lake City | Utah | 84107 | United States |
| Sandy Clinical Site | Sandy City | Utah | 84094 | United States |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000607300 | ONO-2952 |
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