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The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-333 1 mg | Experimental | 1 mg SP-333 orally once daily for 4-week Treatment Period |
|
| SP-333 3 mg | Experimental | 3 mg SP-333 orally once daily for 4-week Treatment Period |
|
| SP-333 6 mg | Experimental | 6 mg SP-333 orally once daily for 4-week Treatment Period |
|
| Placebo | Placebo Comparator | Placebo orally once daily for 4-week Treatment Period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP-333 1 mg | Drug | Tablet |
| |
| SP-333 3 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period | Compare SP-333 (1, 3 & 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC | Compare the safety and tolerability of SP-333 (1, 3 & 6 mg) with placebo as measured by rates of adverse events, clinical laboratory abnormalities and significant changes in vital signs and ECGs. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate stool consistency over the 4-week Treatment Period | Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in stool consistency over the 4 weeks of treatment. | 4 weeks |
| To evaluate constipation-related symptoms over the 4-week Treatment Period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renata Tenenbaum | Synergy Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Research Site | Huntsville | Alabama | 35801 | United States | ||
| Synergy Research Site |
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| Drug |
Tablet |
|
| SP-333 6 mg | Drug | Tablet |
|
| Placebo | Drug | Tablet |
|
Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in constipation-related symptoms over the 4 weeks of treatment. |
| 4 weeks |
| To evaluate bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4-week Treatment Period. | Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline for bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4 weeks of treatment. | 4 weeks |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Synergy Research Site | Phoenix | Arizona | 85018 | United States |
| Synergy Research Site | Artesia | California | 90701 | United States |
| Synergy Research Site | Laguna Hills | California | 92653 | United States |
| Synergy Research Site | Oceanside | California | 92056 | United States |
| Synergy Research Site | Sacramento | California | 95831 | United States |
| Synergy Research Site | San Diego | California | 92103 | United States |
| Synergy Research Site | San Diego | California | 92108 | United States |
| Synergy Research Site | San Francisco | California | 94103 | United States |
| Synergy Research Site | Hialeah | Florida | 33012 | United States |
| Synergy Research Site | Miami | Florida | 33173 | United States |
| Synergy Research Site | Miami Beach | Florida | 33140 | United States |
| Synergy Research Site | Plant City | Florida | 33563 | United States |
| Synergy Research Site | Plantation | Florida | 33317 | United States |
| Synergy Research Site | Port Orange | Florida | 32129 | United States |
| Synergy Research Site | Sarasota | Florida | 34239 | United States |
| Synergy Research Site | West Palm Beach | Florida | 33409 | United States |
| Synergy Research Site | Winter Haven | Florida | 33880 | United States |
| Synergy Research Site | Atlanta | Georgia | 30312 | United States |
| Synergy Research Site | Bloomington | Illinois | 61701 | United States |
| Synergy Research Site | Traverse City | Michigan | 49684 | United States |
| Synergy Research Site | St Louis | Missouri | 63117 | United States |
| Synergy Research Site | Las Vegas | Nevada | 89102 | United States |
| Synergy Research Site | Great Neck | New York | 11023 | United States |
| Synergy Research Site | New York | New York | 10016 | United States |
| Synergy Research Site | Concord | North Carolina | 28025 | United States |
| Synergy Research Site | Greensboro | North Carolina | 27403 | United States |
| Synergy Research Site | Salisbury | North Carolina | 28144 | United States |
| Synergy Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Synergy Research Site | Dayton | Ohio | 45424 | United States |
| Synergy Research Site | Oklahoma City | Oklahoma | 73101 | United States |
| Synergy Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Synergy Research Site | Oklahoma City | Oklahoma | 73119 | United States |
| Synergy Research Site | Medford | Oregon | 97504 | United States |
| Synergy Research Site | Orangeburg | South Carolina | 29118 | United States |
| Synergy Research Site | Chattanooga | Tennessee | 37421 | United States |
| Synergy Research Site | Arlington | Texas | 76012 | United States |
| Synergy Research Site | Dallas | Texas | 75218 | United States |
| Synergy Research Site | Dallas | Texas | 75231 | United States |
| Synergy Research Site | Houston | Texas | 77081 | United States |
| Synergy Research Site | San Antonio | Texas | 78209 | United States |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C000614048 | dolcanatide |
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