Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

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Brief Title

Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

Official Title

Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

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).
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in plasma copeptin levels between baseline and 15 minutes after diclofenac/placebo administration

Secondary Outcome

 Change in serum sodium levels between baseline and 15 minutes after diclofenac/placebo administration

Condition

Hypopituitarism

Intervention

Intravenous Infusion of Diclofenac Sodium

Study Arms / Comparison Groups

 Intravenous Infusion of Diclofenac Sodium
Description:  Intravenous Infusion of Diclofenac Sodium in healthy subjects.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

October 1, 2021

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        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
      

Gender

All

Ages

20 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT05188131

Organization ID

NR-DICLO


Responsible Party

Principal Investigator

Study Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino


Study Sponsor

, , 


Verification Date

January 2022