Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status and phase: Completed; Phase 4

Conditions: Hypopituitarism

Treatments: Drug: Intravenous Infusion of Diclofenac Sodium; Drug: Intravenous Infusion of Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05188131

NR-DICLO

Details and patient eligibility

About

The effects of acute administration of non-steroidal anti-inflammatory drugs (NSAIDs) on the neuroendocrine regulation of hydro-electrolytic metabolism are not precisely known to date.

Although the mechanism by which NSAIDs favor the antidiuretic action of vasopressin (AVP) in the kidney has been partially elucidated, their influence on the mechanisms responsible for regulating its secretion are less known. The interactions between NSAIDs and natriuretic peptides are also not entirely certain.

The present pharmacological research study therefore aims to investigate, in a cohort of healthy subjects, the acute effects of intravenous infusion of diclofenac sodium on the neuroendocrine regulation systems of water and salt balance (i.e. the antidiuretic axis and the system of natriuretic peptides).

Enrollment: 12 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any adult healthy subject (with age 20-50 years old) not meeting any of the exclusion criteria listed below

Exclusion criteria

• BMI < 18.5 kg/m2 or > 25 kg/m2
• Any active pharmacological treatment
• Pregnancy or breastfeeding
• History of polyuria/polydipsia syndrome
• History of dysionia
• History of peptic disease
• History of gastrointestinal bleeding
• History of kidney disease
• History of heart disease
• History of asthma
• Known allergy to NSAIDs
• Any current acute medical condition

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Intravenous Infusion of Diclofenac Sodium

Experimental group

Description:

Intravenous Infusion of Diclofenac Sodium in healthy subjects.

Treatment:

Drug: Intravenous Infusion of Diclofenac Sodium

Intravenous Infusion of Placebo

Placebo Comparator group

Description:

Intravenous Infusion of Placebo (isotonic saline) in healthy subjects.

Treatment:

Drug: Intravenous Infusion of Placebo