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This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS995 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| - 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol. | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| - colorectal compliance | throughout the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| NOVARTIS | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Boston | Massachusetts | 02215 | United States | ||
| Novartis Investigator Site |
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| Drug |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Novartis Investigator Site | Hamilton | Canada |
| Novartis Investigator Site | Gothenburg | Sweden |
| Novartis Investigator Site | London | United Kingdom |
| Novartis Investigator Site | Manchester | United Kingdom |
| Novartis Investigator Site | Nottingham | United Kingdom |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D004108 | Dilatation, Pathologic |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004194 | Disease |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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