A Phase 4 interventional study of Intravenous Infusion of Diclofenac Sodium and Intravenous Infusion of Placebo in Hypopituitarism, sponsored by A.O.U. Città della Salute e della Scienza. Completed at 1 site in Italy. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by A.O.U. Città della Salute e della Scienza · Phase 4, Interventional, and Diagnostic
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).
47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 29 interventional studies indexed under Hypopituitarism.
Browse Hypopituitarism studies →A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous Infusion of Diclofenac Sodium in healthy subjects.
Drug: Intravenous Infusion of Diclofenac Sodium
Intravenous Infusion of Placebo (isotonic saline) in healthy subjects.
Drug: Intravenous Infusion of Placebo
Intravenous Infusion of Diclofenac Sodium is administered at the dose of 75 mg, diluted in 100 ml of isotonic saline, over 15 minutes.
Intravenous Infusion of Placebo (represented by 100 ml of isotonic saline) is administered over 15 minutes.
Change in plasma copeptin levels between baseline and 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.
Time frame: From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
Change in plasma copeptin levels between baseline and 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.
Time frame: From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
Change in plasma copeptin levels between baseline and 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.
Time frame: From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
Change in plasma copeptin levels between baseline and 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.
Time frame: From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
Change in plasma copeptin levels between baseline and 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.
Time frame: From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
Change in plasma copeptin levels between baseline and 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.
Time frame: From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
Change in plasma copeptin levels between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in plasma MR-proANP levels between baseline and 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.
Time frame: From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
Change in plasma MR-proANP levels between baseline and 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.
Time frame: From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
Change in plasma MR-proANP levels between baseline and 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.
Time frame: From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
Change in plasma MR-proANP levels between baseline and 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.
Time frame: From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
Change in plasma MR-proANP levels between baseline and 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.
Time frame: From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
Change in plasma MR-proANP levels between baseline and 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.
Time frame: From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
Change in plasma MR-proANP levels between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in serum sodium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
Change in serum sodium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
Change in serum sodium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
Change in serum sodium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
Change in serum sodium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
Change in serum sodium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
Change in serum sodium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in plasma MR-proADM levels between baseline and 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.
Time frame: From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
Change in plasma MR-proADM levels between baseline and 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.
Time frame: From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
Change in plasma MR-proADM levels between baseline and 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.
Time frame: From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
Change in plasma MR-proADM levels between baseline and 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.
Time frame: From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
Change in plasma MR-proADM levels between baseline and 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.
Time frame: From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
Change in plasma MR-proADM levels between baseline and 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.
Time frame: From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
Change in plasma MR-proADM levels between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in urine sodium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in urine potassium levels between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in urine osmolality between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in resistance at bioimpedance vector analysis between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in reactance at bioimpedance vector analysis between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in phase angle at bioimpedance vector analysis between baseline and 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.
Time frame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Change in late-night salivary cortisol levels between 9 hours before and 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.
Time frame: From 9 hours before to 15 hours after diclofenac/placebo administration
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A.O.U. Città della Salute e della Scienza