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The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic human secretin) with MRCP in subjects with abnormalities of the pancreas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG1068 (synthetic human secretin) | Drug | Single-dose, IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities. | 0 - 10 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome measure will assess safety | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Jacoby, MD, PhD | Repligen Corporation | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24906040 | Derived | Sherman S, Freeman ML, Tarnasky PR, Wilcox CM, Kulkarni A, Aisen AM, Jacoby D, Kozarek RA. Administration of secretin (RG1068) increases the sensitivity of detection of duct abnormalities by magnetic resonance cholangiopancreatography in patients with pancreatitis. Gastroenterology. 2014 Sep;147(3):646-654.e2. doi: 10.1053/j.gastro.2014.05.035. Epub 2014 Jun 4. |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012633 | Secretin |
| ID | Term |
|---|---|
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
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| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |