ClinicalTrials.gg
CompletedNCT05890690URANOSUpdated Jul 9, 2024

Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome

An interventional study of Urea and Placebo in Arginine Vasopressin Deficiency and Primary Polydipsia, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic

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Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies in Diabetes Insipidus, Neurogenic by University Hospital, Basel, Switzerland — 7 open to participants now, 7 under way, none of them phase 3. Diabetes Insipidus, Neurogenic · University Hospital, Basel, Switzerland.

Enrollment
3rd of 11
48 · median 42
Started
2023
the only one that year
No phase
8 of 11
4 open now
Registered
3rd of 11
by date

Among the 11 studies in Diabetes Insipidus, Neurogenic by University Hospital, Basel, Switzerland, this one is the 3rd largest by enrollment, is the only one that started in 2023, is one of 8 with no phase, and was the 3rd registered.

Diabetes Insipidus, Neurogenic

27 studies on the registry are indexed under Diabetes Insipidus, Neurogenic; 12 are open to participants now.

Browse Diabetes Insipidus, Neurogenic studies →

Open to participants now

7 of the 11 studies in Diabetes Insipidus, Neurogenic by University Hospital, Basel, Switzerland are open now, in 3 countries. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 11 Diabetes Insipidus, Neurogenic studies recruiting now, 8 (73%) set no upper age limit and 3 (27%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Diabetes Insipidus, Neurogenic by University Hospital, Basel, Switzerland, or all of them as a file.
02

Study summary

The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia).

Read the detailed description

This study consists of two parts, including healthy adults (study part 1 - proof of concept) and adults with an established diagnosis of PP or AVP-D (study part 2 - pilot study).

If the results of study part 1 suggest that oral urea is a potent stimulator of copeptin in healthy adults, study part 2 will be conducted, meaning that adults with an established diagnosis of PP or AVP-D will be included. If study part 1 demonstrates no relevant copeptin increase in response to oral urea, the study will be terminated thereafter and study part 2 will not be conducted.

03

Conditions studied

  • Arginine Vasopressin Deficiency
  • Primary Polydipsia

Keywords

  • diabetes insipidus
  • copeptin
  • oral urea
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Healthy with no medication except hormonal

Exclusion Criteria:

  • Participation in a trial with drugs within 30 days
  • Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h
  • Known allergy towards components of the study drink
  • Pregnancy and breastfeeding
  • Intention to become pregnant during the study
  • Evidence of acute illness

Patients

Inclusion Criteria:

  • Age ≥ 18 years
  • Documented PP or AVP-D based on accepted diagnostic criteria, i.e., water deprivation test, hypertonic saline infusion test or arginine infusion test. Accordingly, patients must have evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h or must be on regular daily desmopressin medication

Exclusion Criteria:

  • Participation in a trial with investigational drugs within 30 days
  • Known allergy towards components of the study drink
  • Pregnancy and breastfeeding
  • Evidence of acute illness
Terms in these criteria, in plain language(2)

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.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Study Part 1 urea followed by placebo

    Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea first. After a a wash-out phase of at least 3 days and not more than 28 days participants will undergo a second diagnostic test with a single weight-adapted dose of placebo.

    Diagnostic Test: Urea · Diagnostic Test: Placebo

  • Experimental
    Study Part 1 placebo followed by urea

    Participants will undergo a diagnostic test with a single weight-adapted dose of placebo first. After a a wash-out phase of at least 3 days and not more than 28 days participants will undergo a second diagnostic test with a single weight-adapted dose of urea.

    Diagnostic Test: Urea · Diagnostic Test: Placebo

  • Experimental
    Study part 2 Urea

    Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea

    Diagnostic Test: Urea

Interventions

  • Diagnostic testUrea

    Diagnostic test with a single weight-adapted dose of oral urea dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid). The investigators will make use of the lemon-lime flavor to soften the bitter taste of urea. - Dose calculation: 0.5 g urea/kg body weight (rounded to no decimal places), with a minimal dose of 30g and a maximal dose of 45g.

  • Diagnostic testPlacebo

    Diagnostic test with a single weight-adapted dose of placebo dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid). The placebo will contain a mixture of bitter herbal substances to mimic the taste of urea. - Dose calculation: 22 ml of placebo containing 20 ml Ergytonyl®, 1 ml Carmol®, and 1 ml Bitter Liebe®.

06

What researchers measure

Primary outcomes

  1. Difference in maximal increase in copeptin levels in plasma (pmol/l)

    The difference in maximal increase in copeptin levels in plasma (pmol/l) within 150 minutes after oral intake of urea versus placebo, with the maximal increase being the difference between baseline copeptin values measured at the beginning of the test and maximal values measured between 30 and 150 minutes after ingestion.

    Time frame: up to 6 time assessment until 150 minutes after baseline

07

Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Jun 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2023
First posted
Jun 6, 2023
StartActual
Jun 2, 2023
Primary completionActual
Jun 24, 2024
CompletionActual
Jun 24, 2024
Last update
Jul 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05890690
Responsible party
Sponsor
First posted
Jun 6, 2023
Start date
Jun 2, 2023
Primary completion
Jun 24, 2024
Completion
Jun 24, 2024
Last update
Jul 9, 2024

Study contacts

Mirjam Christ-Crain, Prof.
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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