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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000313-30 |
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The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 30 mg, oral, single dose |
|
| 2 | Experimental | 95 mg, oral, single dose |
|
| 3 | Placebo Comparator | Oral solution, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | oral, single dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| VAS scale and clock | Several occasions during the study days |
| Measure | Description | Time Frame |
|---|---|---|
| VAS scale and pressure, VAS scale and current, VAS scale and acid volume | Several occasions during the study days | |
| Pharmacokinetic variables | Several occasions during the study days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Sundin | AstraZeneca R&D, Mölndal, Sweden | Study Director |
| Peter Funch-Jensen, MD, PhD | Aarhus University Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aarhus | Denmark | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21410733 | Derived | Krarup AL, Ny L, Astrand M, Bajor A, Hvid-Jensen F, Hansen MB, Simren M, Funch-Jensen P, Drewes AM. Randomised clinical trial: the efficacy of a transient receptor potential vanilloid 1 antagonist AZD1386 in human oesophageal pain. Aliment Pharmacol Ther. 2011 May;33(10):1113-22. doi: 10.1111/j.1365-2036.2011.04629.x. Epub 2011 Mar 16. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
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| ID | Term |
|---|---|
| C574562 | AZD1386 |
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| Drug |
Oral solution, single dose |
|
| Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature) |
| Several occasions during the study days |
| Gothenburg |
| Sweden |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |