Novo Nordisk Clinical Innovation Centre A/S
Gentofte Municipality, 2820, Denmark
Location status: Recruiting
NCT Number: NCT07769489
The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Participants will be in this clinical study for about 1 week.
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Phase 1
Gentofte Municipality, 2820, Denmark
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device used for delivery of subcutaneous injections and infusions of NaCl solution.
Time frame: 1 minute (±1 minute) from the injection initiation
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in millimetres (mm).
Time frame: 9 minutes (±1minute) from the injection initiation
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in mm.
Time frame: 1 minute (±1 minute) from the injection initiation
Measured as binary response (Acceptable/Not acceptable).
Time frame: 5 minutes (±1 minute) from the injection initiation
Measured in microlitres (μL).
Time frame: 9 minutes (±1 minute) from the injection initiation
Measured in injection site reactions (events).
Time frame: 16-40 hours after all injections with an additional 36 hours if a clinic visit is needed
Measured in injection site reactions (events).
Time frame: Up to 40 hours after completing all the injections with an additional 36 hours if a clinic visit is needed
Measured in events.
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
An Exploratory Study to Investigate Pain Related to Injection of Large Volumes (up to 5mL) Subcutaneously
Acronym: RISE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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