Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05188131

Enrollment

Registered

2022-01-12

Start date

2021-10-01

Completion date

2021-12-31

Last updated

2022-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopituitarism

Brief summary

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).

Interventions

DRUGIntravenous Infusion of Diclofenac Sodium

Intravenous Infusion of Diclofenac Sodium is administered at the dose of 75 mg, diluted in 100 ml of isotonic saline, over 15 minutes.

DRUGIntravenous Infusion of Placebo

Intravenous Infusion of Placebo (represented by 100 ml of isotonic saline) is administered over 15 minutes.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

\- Any adult healthy subject (with age 20-50 years old) not meeting any of the

Exclusion criteria

listed below

Design outcomes

Primary

Measure	Time frame	Description
Change in plasma copeptin levels between baseline and 15 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration	The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 30 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration	The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 45 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration	The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 60 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration	The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 90 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration	The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 120 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration	The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 15 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration	The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 30 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration	The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 45 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration	The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 60 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration	The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 90 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration	The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 120 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration	The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.

Secondary

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Measure	Time frame	Description
Change in urine sodium levels between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine sodium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in urine potassium levels between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine potassium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in urine osmolality between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine osmolality (mOsm/kg) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 15 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Change in reactance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring reactance (Ohm) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in phase angle at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring phase angle (°) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in late-night salivary cortisol levels between 9 hours before and 15 hours after diclofenac/placebo administration	From 9 hours before to 15 hours after diclofenac/placebo administration	The influence the administration of intravenous diclofenac sodium, compared to placebo, on late-night salivary cortisol was evaluated by measuring late-night salivary cortisol (ng/ml) at 11 pm the day before diclofenac/placebo administration, and at 11 pm the day of diclofenac/placebo administration.
Change in resistance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis was evaluated by measuring resistance (Ohm) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 30 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 45 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 60 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 90 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 120 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 15 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 30 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 45 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 60 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 90 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 120 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 240 minutes after diclofenac/placebo administration	From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration	The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.