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The purpose of the study is to evaluate the influence of needle size, injected fluid volume, and rate of fluid on the degree of pain experienced by adult healthy volunteers after subcutaneous infusion of sterile saline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Infusion of Sterile Saline | Experimental | Participants will receive sterile saline subcutaneous infusion administered into abdomen and/or anterior thigh through various sizes of needles at various volume and rate of delivery at Visit 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile Saline | Other | Sterile saline will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score | Participant's pain intensity during or after the saline infusion as assessed by VAS score will be reported. VAS is a self-reported pain rating scale ranging 0=no pain to 100=worst possible pain. | Up to 10 minutes after completion of the saline infusion |
| Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS) | Participant's pain intensity during or after the saline infusion as assessed by VPS will be reported. VPS will be graded by participants as none, mild, moderate, and severe. | Up to 10 minutes after completion of the saline solution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19148 | United States |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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