Urine Specimen CollectionPhase 3NCT04338477
Study to Assess Safety and Efficacy of Nephrosolid Tbs to Stimulate Urinary Output in Non-patient Volunteers
A Phase 3 study testing Nephrosolid tablets in people with Urine Specimen Collection, run by A. Vogel AG at 2 sites in Switzerland.
Trial summary
Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Urine Specimen Collection
- What is being tested?
- Nephrosolid tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 12 Feb 2018to 31 Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness and ability to record urine volume and fluid consumption over 3 days.
- Written consent to participate in the study.
Who cannot join
- Disease or comprehension problems (language) that affect the accurate collection and measurement of urine levels over 3 days.
- Taking diuretic drugs, teas, herbal supplements, or systemic corticosteroids.
- Chronic nephropathy (such as glomerulonephritis, analgesic nephropathy, interstitial nephritis).
- Pregnancy or lactation.
- Psychiatric disorders that include suicidality.
- Surgical intervention in the 3 months prior to enrollment or scheduled surgery during the study.
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- Known chronic diseases such as dementia, progressive systemic diseases.
- Known alcohol and/or drug addiction.
- Known allergies to goldenrod or birch leaves.
- Participation in one or more other clinical trials in the last 30 days
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Privat practice of Dr. med. Bruno Haug, Medizinisches Zentrum Arbon
Arbon, Thurgau, 9320
Private Practice Dr. med Bernhard Waelti
Freidorf, Thurgau, 9306
About this study
Official title: Multizentrische, Offene Studie Zur Beurteilung Der Verträglichkeit Und Wirksamkeit Von Nephrosolid Tabletten Zur Anregung Der Harnausscheidung Bei Probanden/Non-patient Volunteers
Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy.
Read the detailed description
To evaluate safety and efficacy of Nephrosolid tbs in the stimulation of urinary output in healthy volunteers, all participants in this open-label study will be asked to record their fluid intake and output on day 0 (without study medication), on day 1 (with 3 x 2 tablets study medication, to be taken 1/2 hour before meals) and on day 28 (with 2 x 1 tablets study medication, morning and noon half an hour before meals) and to take 2 x 1 tablet of Nephrosolid on days 2-28. Subjects will complete a diary during the study to record the tablets taken, amount of fluid consumed, weight, physical activity, and urinary measurement. Safety labs (hematology, clinical chemistry) will be performed at each study visit on days -1 and 29.
- Conditions
- Urine Specimen Collection
- Being tested
- Nephrosolid tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nephrosolid tabletsDrug
Adminstration of drug
| Study group | Role | What they receive |
|---|---|---|
| Nephrosolid | Experimental | Acute dosis day 1: 3X2 Nephrosolid tablets 0.5 h before intake of a meal Long-term dosis days 2-28: 2x1 Nephrosolid tablets 0.5 h before intake of a meal Receives: Drug: Nephrosolid tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability as assessed by the treating physician
Tolerability is assessed at 2nd visit /study end, after 4 weeks of intake, according to four step scale ( poor, moderate, good, very good)
Measured: day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start12 Feb 2018
- Primary completion17 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Specimen CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernhard Waelti, Dr. med., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338477
- Sponsor's protocol ID
- 920174
- Status last verified
- Apr 2020
- First submitted
- 4 Jan 2018
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multizentrische, Offene Studie Zur Beurteilung Der Verträglichkeit Und Wirksamkeit Von Nephrosolid Tabletten Zur Anregung Der Harnausscheidung Bei Probanden/Non-patient Volunteers
- ClinicalTrials.gov ID
- NCT04338477
- Acronym / sponsor ID
- 920174
- Conditions
- Urine Specimen Collection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy.
Detailed description
To evaluate safety and efficacy of Nephrosolid tbs in the stimulation of urinary output in healthy volunteers, all participants in this open-label study will be asked to record their fluid intake and output on day 0 (without study medication), on day 1 (with 3 x 2 tablets study medication, to be taken 1/2 hour before meals) and on day 28 (with 2 x 1 tablets study medication, morning and noon half an hour before meals) and to take 2 x 1 tablet of Nephrosolid on days 2-28. Subjects will complete a diary during the study to record the tablets taken, amount of fluid consumed, weight, physical activity, and urinary measurement. Safety labs (hematology, clinical chemistry) will be performed at each study visit on days -1 and 29.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nephrosolid | Experimental | Drug: Nephrosolid tabletsAcute dosis day 1: 3X2 Nephrosolid tablets 0.5 h before intake of a meal Long-term dosis days 2-28: 2x1 Nephrosolid tablets 0.5 h before intake of a meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willingness and ability to record urine volume and fluid consumption over 3 days.
- Written consent to participate in the study.
Key exclusion criteria (10 listed)
- Disease or comprehension problems (language) that affect the accurate collection and measurement of urine levels over 3 days.
- Taking diuretic drugs, teas, herbal supplements, or systemic corticosteroids.
- Chronic nephropathy (such as glomerulonephritis, analgesic nephropathy, interstitial nephritis).
- Pregnancy or lactation.
- Psychiatric disorders that include suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nephrosolid tabletsAdminstration of drug | Drug | Nephrosolid |
Primary outcome
Tolerability as assessed by the treating physician
Time frame: day 29
Tolerability is assessed at 2nd visit /study end, after 4 weeks of intake, according to four step scale ( poor, moderate, good, very good)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Waelti, Dr. med. principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nephrosolid tablets in people with Urine Specimen Collection, run by A. Vogel AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability as assessed by the treating physician (time frame: day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.