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The purpose of this trial is to evaluate the effect of a single PPC-5650 dose in a human pain model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the esophagus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo solution | Placebo Comparator | A 100 ml placebo solution will be administered through an esophageal probe. 100 ml will be administered as an infusion with a rate of 7ml/min. Healthy volunteers will be treated with placebo in one out of three visit days. |
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| PPC-5650 | Active Comparator | PPC-5650 is a "asic-sensing ion channel"-1a antagonist that can block the acid-sensing ion channels, leading to a reduction in the pain signal under up-regulated conditions. A dose of 2.5 mg PPC-5650 in a 100 ml solution will be administered through an esophageal probe to assess local effects. 100 ml will be administered as an infusion with a rate of 7ml/min. Healthy volunteers will be treated with PPC-5650 in one out of three visit days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPC-5650 | Drug | A dose of 2.5 mg PPC-5650 in a 100 ml solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical) | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of observed adverse effects (safety profile) and changes in size of referred pain area | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asbjørn M Drewes, Professor | Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital | Aalborg | Jutland | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25483563 | Derived | Olesen AE, Nielsen LM, Larsen IM, Drewes AM. Randomized clinical trial: efficacy and safety of PPC-5650 on experimental esophageal pain and hyperalgesia in healthy volunteers. Scand J Gastroenterol. 2015 Feb;50(2):138-44. doi: 10.3109/00365521.2014.966319. Epub 2014 Dec 8. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo | Drug | A 100 ml placebo solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days. |
|
| D004066 | Digestive System Diseases |