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Injection Site Pain Comparison of Excipient Solutions

18. oktober 2021 oppdatert av: Novo Nordisk A/S

A Trial to Assess the Injection Site Pain Experience of Excipient Solutions Relevant for Subcutaneous Injection

The purpose of this study is to investigate different solutions used to inject drugs under the skin. The solutions used in the study do not contain the drugs they will be used for, but they do contain excipients, which are inactive substances added to drug solutions to ensure the stability (shelf life and correct activity) of the drug product. The excipients are considered 'inactive substances' compared to the drug, but they may cause an undesirable effect at the injection site in the form of pain. However, their pain-causing potential has never been tested in a systematic way. The purpose of the study is to determine if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 12 different study products. These study products are excipient solutions, which are substances in medications next to the active substance. None of the 12 products include active medication. This study will be performed in 108 healthy male and female volunteers.

Studieoversikt

Status

Fullført

Forhold

Overvekt

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

108

Fase

Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Nederland
- - Groningen, Nederland, 9728 NZ
    - Novo Nordisk Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Male or female, aged 18 to 69 years (both inclusive) at the time of signing informed consent.
Body Mass Index (BMI) equal to or above 25.0 and below 30.0 kg/m^2.
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.

Exclusion Criteria:

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) equal to or above 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Annen
Tildeling: Randomisert
Intervensjonsmodell: Sekvensiell tildeling
Masking: Firemannsrom

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: S1 Day 1: Trial products 1-2-12-3-11-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 10-5-9-6-8-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S2 Day 1: Trial products 2-3-1-4-12-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 11-6-10-7-9-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S3 Day 1: Trial products 3-4-2-5-1-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 12-7-11-8-10-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S4 Day 1: Trial products 4-5-3-6-2-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 1-8-12-9-11-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S5 Day 1: Trial products 5-6-4-7-3-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 2-9-1-10-12-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S6 Day 1: Trial products 6-7-5-8-4-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 3-10-2-11-1-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S7 Day 1: Trial products 7-8-6-9-5-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 4-11-3-12-2-1-given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S8 Day 1: Trial products 8-9-7-10-6-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 5-12-4-1-3-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S9 Day 1: Trial products 9-10-8-11-7-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 6-1-5-2-4-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S10 Day 1: Trial products 10-11-9-12-8-1 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 7-2-6-3-5-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S11 Day 1: Trial products 11-12-10-1-9-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 8-3-7-4-6-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
Eksperimentell: S12 Day 1: Trial products 12-1-11-2-10-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 9-4-8-5-7-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.	Annen: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Annen: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Annen: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Annen: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Annen: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Annen: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Annen: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Annen: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Annen: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Annen: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Annen: Trial product 12 Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Intensity of injection site pain Tidsramme: 1 min after each injection (Day 1 and Day 2)	mm on a 100 mm horizontal visual-analogue scale (where 0 mm = no pain, 100 mm = unbearable pain)	1 min after each injection (Day 1 and Day 2)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novo Nordisk A/S

Etterforskere

Studieleder: Clinical Reporting Anchor and Disclosur (1452), Novo Nordisk A/S

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. juli 2020

Primær fullføring (Faktiske)

24. september 2020

Studiet fullført (Faktiske)

25. september 2020

Datoer for studieregistrering

Først innsendt

20. juli 2020

Først innsendt som oppfylte QC-kriteriene

20. juli 2020

Først lagt ut (Faktiske)

22. juli 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

NN9838-4703
U1111-1250-7817 (Annen identifikator: World Health Organization (WHO))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Trial product 1

Radicle Science

Aktiv, ikke rekrutterende

Radicle Clarity: En studie av helse- og velværeprodukter på mental klarhet og helseresultater

Kognitiv funksjon

Forente stater
Radicle Science

Aktiv, ikke rekrutterende

Radicle Clarity 24: En studie av helse- og velværeprodukter på kognitiv funksjon og relaterte helseresultater

Kognitiv funksjon

Forente stater
Radicle Science

Rekruttering

Radicle Relief 2: En studie av helse- og velværeprodukter på smerte og helseutfall

Smerte | Nevropatisk smerte | Nociseptiv smerte

Forente stater
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)

Avsluttet

Perifer vasodilatasjon hos overvektige mennesker (ObeseDilate)

Overvekt

Forente stater
NYU Langone Health

Tilbaketrukket

Datastyrt kognitiv trening for pasienter med epilepsi

Epilepsi

Forente stater
Saluda Medical Pty Ltd

Fullført

Sikkerhet og effektivitet av ryggmargsstimulering med automatisk kontroll for å behandle kroniske smerter i en utvidet prøveperiode (Panorama)

Kronisk smerte

Forente stater
University of Newcastle, Australia
Queen Margaret University

Fullført

Fotortoser (FOs) om smerter, livskvalitet og gange med barn diagnostisert med JIA

Leddgikt, juvenil revmatoid

Australia
Michael Sekela

Fullført

Stamcellehjerteinjeksjoner under laserrevaskulariseringskirurgi for behandling av kronisk iskemisk hjertesykdom

Kronisk iskemisk hjertesykdom

Forente stater
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)

Fullført

Trial of Activity for Adolescent Girls (TAAG) (TAAG)

Hjertesykdommer | Kardiovaskulære sykdommer | Overvekt
Universidad Europea de Madrid

Fullført

Vurdering av den akutte effekten av sykkelpraksis i lumbale og lårmuskler

Muskel- og skjelettsmerter | Muskeltretthet | Muskelstramming | Fysisk utholdenhet

Spania

Injection Site Pain Comparison of Excipient Solutions

A Trial to Assess the Injection Site Pain Experience of Excipient Solutions Relevant for Subcutaneous Injection

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Studietype

Registrering (Faktiske)

Fase

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Etterforskere

Studierekorddatoer

Studer hoveddatoer

Studiestart (Faktiske)

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Faktiske)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt

Kliniske studier på Trial product 1

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Burundi

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder