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Injection Site Pain Comparison of Excipient Solutions

18. Oktober 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Fettleibigkeit

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

108

Phase

Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Kind
Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Sonstiges
Zuteilung: Zufällig
Interventionsmodell: Sequenzielle Zuweisung
Maskierung: Vervierfachen

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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
Experimental: 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.	Sonstiges: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Sonstiges: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Sonstiges: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Sonstiges: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Sonstiges: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Sonstiges: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Sonstiges: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Sonstiges: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Sonstiges: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Sonstiges: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Sonstiges: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Intensity of injection site pain Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Novo Nordisk A/S

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. Juli 2020

Primärer Abschluss (Tatsächlich)

24. September 2020

Studienabschluss (Tatsächlich)

25. September 2020

Studienanmeldedaten

Zuerst eingereicht

20. Juli 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Juli 2020

Zuerst gepostet (Tatsächlich)

22. Juli 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Oktober 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Oktober 2021

Zuletzt verifiziert

1. Oktober 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

NN9838-4703
U1111-1250-7817 (Andere Kennung: World Health Organization (WHO))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Trial product 1

NYU Langone Health

Zurückgezogen

Computergestütztes kognitives Training für Patienten mit Epilepsie

Epilepsie

Vereinigte Staaten
University of Pennsylvania

Rekrutierung

Reduzierung des Erinnerungsrückrufs von Patienten in der Patientenpopulation mit brennendem Mund

Burning-Mouth-Syndrom

Vereinigte Staaten
Mirum Pharmaceuticals, Inc.

Rekrutierung

Langzeitstudie mit geringem Eingriff zur Sicherheit und klinischen Ergebnissen von LivmArli® bei Patienten mit Alagille-Syndrom in der Europäischen Union (LEAP-EU)

Alagille-Syndrom | Progressive familiäre intrahepatische Cholestase

Deutschland, Spanien, Niederlande, Frankreich, Italien, Belgien, Griechenland, Portugal
Sara Farag

Abgeschlossen

Harnverhalt nach totaler laparoskopischer Hysterektomie mit sofortiger Entfernung des Foley-Katheters versus Backfill-Void-Studie

Miktionsstörungen | Harnverhalt

Vereinigte Staaten
Radicle Science

Abgeschlossen

Radicle GI Health ™: Eine Studie zur Bewertung der Auswirkungen von Gesundheit und Wellnessprodukten auf Magen -Darm (GI) Gesundheit

GI-Gesundheit

Vereinigte Staaten
McMaster University
Canadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated...

Rekrutierung

Neubewertung der Hemmung von Stresserosionen (REVISE) – COVID-19-Kohortenstudie

COVID-19 | Magen-Darm-Blutungen

Kanada
GE Healthcare

Abgeschlossen

Studie zur Verbesserung der Intensivpflege (Pilot)

Sedierte Intensivpatienten

Vereinigtes Königreich
Radicle Science

Abgeschlossen

Radicle Spark for Women ™ 24: Bewertung der Auswirkungen von Gesundheit und Wellnessprodukten auf die sexuelle Gesundheit und die damit verbundenen Gesundheitsergebnisse

Sexuelle Funktion | Sexuelle Befriedigung

Vereinigte Staaten
Fakultas Kedokteran Universitas Indonesia

Unbekannt

Flüssiges Nahrungsergänzungsmittel für unterernährte Krankenhauspatienten

Unterernährung

Indonesien
University of California, Los Angeles

Aktiv, nicht rekrutierend

PRISM-Interventionsstudie

Autismus-Spektrum-Störung

Vereinigte Staaten

Injection Site Pain Comparison of Excipient Solutions

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

Studienübersicht

Status

Bedingungen

Intervention / Behandlung

Studientyp

Einschreibung (Tatsächlich)

Phase

Kontakte und Standorte

Studienorte

Teilnahmekriterien

Zulassungskriterien

Studienberechtigtes Alter

Akzeptiert gesunde Freiwillige

Studienberechtigte Geschlechter

Beschreibung

Studienplan

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm

Intervention / Behandlung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme

Maßnahmenbeschreibung

Zeitfenster

Mitarbeiter und Ermittler

Sponsor

Ermittler

Studienaufzeichnungsdaten

Haupttermine studieren

Studienbeginn (Tatsächlich)

Primärer Abschluss (Tatsächlich)

Studienabschluss (Tatsächlich)

Studienanmeldedaten

Zuerst eingereicht

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Zuerst gepostet (Tatsächlich)

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Zuletzt verifiziert

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Beschreibung des IPD-Plans

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Klinische Studien zur Trial product 1

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Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Trinidad & Tobago

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte