Injection Site Pain Comparison of Excipient Solutions
18 octobre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
108
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Groningen, Pays-Bas, 9728 NZ
- Novo Nordisk Investigational Site
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
|
Expérimental: 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. |
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intensity of injection site pain
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Reporting Anchor and Disclosur (1452), Novo Nordisk A/S
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 juillet 2020
Achèvement primaire (Réel)
24 septembre 2020
Achèvement de l'étude (Réel)
25 septembre 2020
Dates d'inscription aux études
Première soumission
20 juillet 2020
Première soumission répondant aux critères de contrôle qualité
20 juillet 2020
Première publication (Réel)
22 juillet 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 octobre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 octobre 2021
Dernière vérification
1 octobre 2021
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- NN9838-4703
- U1111-1250-7817 (Autre identifiant: World Health Organization (WHO))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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VA Eastern Colorado Health Care SystemNational Kidney Foundation, United States; Food Bank of the RockiesRecrutementMaladies rénales | Hypertension | Diabète | Insécurité alimentaire / nutritionÉtats-Unis
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Mark J Rzeszutek, PhDNational Institute on Drug Abuse (NIDA)ComplétéConsommation d'alcool | Utilisation de la cigarette électronique | Consommation de cigarettesÉtats-Unis