A trial to assess the injection site pain experience of excipient solutions relevant for subcutaneous injectio
- Conditions
- n.a.
- Registration Number
- NL-OMON50101
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
•Male or female, aged 18 to 69 years (both inclusive) at the time of signing
informed consent.
•BMI >=25.0 and <30.0 kg/m2.
•Considered to be generally healthy based on the medical history, physical
examination, and the results of vital signs, electrocardiogram (ECG), and
clinical laboratory tests performed during the screening visit, as judged by
the Investigator.
•Female who is pregnant, breast-feeding or intends to become pregnant within 1
week of Day 2 or is of childbearing potential and not using highly effective
contraceptive methods.
•Any disorder which in the Investigator*s opinion might jeopardise subject*s
safety, evaluation of results, or compliance with the protocol.
•Glycated haemoglobin (HbA1c) >=6.5 % (48 mmol/mol) at screening.
•Use of prescription medicinal products or non-prescription drugs or herbal
products, except routine vitamins, topical medication (when not used in the
abdominal area), contraceptives or occasional use of paracetamol (not allowed
within 24 hours prior to Trial Product administration), within 14 days prior to
Day 1.
•Average intake of more than 21 units of alcohol per week for male subjects and
more than 14 units per week for female subjects: 1 unit of alcohol equals
approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
•Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
antidepressants, and alcohol) at screening and admission to the clinical
research centre.
•Use of tobacco and nicotine products, defined as any of the below:
-Smoking more than 1 cigarette or the equivalent per day on average.
-Not able or willing to refrain from smoking and use of nicotine substitute
products during the in-house period.
•Subject is not able to understand and read English or Dutch, or subject is not
able to understand and comply with the trial requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Intensity of injection site pain.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Exploratory:<br /><br>-Categorical assessment of intensity of injection site pain<br /><br>-Quality of pain<br /><br>-Duration of pain</p><br>