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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000419-15 |
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The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platform II, PASS, ARG 100 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation buffers | Other | Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative perception of pain of platform II versus PASS using a likert scale | 0 minute after injections | |
| Relative perception of pain of platform II versus PASS using a likert scale | 2 minute after injections | |
| Relative perception of pain of PASS versus Arg 100 using a likert scale | 0 minute after injections | |
| Relative perception of pain of PASS versus Arg 100 using a likert scale | 2 minute after injections | |
| Perception of pain of Platform II, PASS and Arg 100 using VAS scale. | 0 minute after injections | |
| Perception of pain of Platform II, PASS and Arg 100 using VAS scale. | 2 minute after injections | |
| Perception of burning of Platform II, PASS and Arg 100 using VAS scale. | 0 minute after injections | |
| Perception of burning of Platform II, PASS and Arg 100 using VAS scale. | 2 minute after injections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josefin-Beate Holz | Ablynx, a Sanofi company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Brussels | B-1070 | Belgium |
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