Nocturia Due to Nocturnal PolyuriaPhase 2NCT03116191
Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
A Phase 2 study testing SK-1404 in people with Nocturia Due to Nocturnal Polyuria, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Nocturia Due to Nocturnal Polyuria
- What is being tested?
- SK-1404
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteJapan
- Study dates
- 23 Feb 2017to 15 Dec 2017
- Phase
- Phase 2
- 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 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5 > nocturnal voids ≥2
- NPI >0.33
Who cannot join
- Polydipsia
- Cardiac failure
- Syndrome of inappropriate antidiuretic hormone secretion
- Hyponatraemia
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
Show all 13Show fewer
- Moderate or severe over-active bladder (OAB)
- Severe benign prostate hyperplasia (BPH)
- Sleep apnoea
- Interstitial cystitis
- Stress urinary incontinence
- Diabetes insipidus
- Complication or a history of urological cancer
Trial locations and contacts
1 site in 1 country.
Japan1 site
Investigational site (there may be other sites in this country)
Tokyo
About this study
The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.
- Conditions
- Nocturia Due to Nocturnal Polyuria
- Being tested
- SK-1404, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-1404Drug
4 weeks of repeated administration of SK-1404 to the patients of nocturia
PlaceboDrug
4 weeks of repeated administration of Placebo to the patients of nocturia
| Study group | Role | What they receive |
|---|---|---|
| SK-1404 high dose | Experimental | Not described Receives: Drug: SK-1404 |
| SK-1404 middle dose | Experimental | Not described Receives: Drug: SK-1404 |
| SK-1404 low dose | Experimental | Not described Receives: Drug: SK-1404 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean number of nocturnal voids
Assessed by the voiding diary
Measured: 4 weeks
Secondary outcomes (4)
Change from base line in mean nocturnal urine volume
Assessed by the voiding diary
Measured: 4 weeks
Change from base line in mean time to first awakening to void
Assessed by the voiding diary
Measured: 4 weeks
Change from base line in mean Nocturnal Polyuria Index (NPI)
Assessed by the voiding diary
Measured: 4 weeks
Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)
Assessed by the voiding diary
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start23 Feb 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturia Due to Nocturnal PolyuriaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116191
- Sponsor's protocol ID
- VA1001
- Status last verified
- Apr 2018
- First submitted
- 6 Apr 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
- ClinicalTrials.gov ID
- NCT03116191
- Acronym / sponsor ID
- VA1001
- Conditions
- Nocturia Due to Nocturnal Polyuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 14 Apr 2017 (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.
The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SK-1404 high dose | Experimental | Drug: SK-1404 |
| SK-1404 middle dose | Experimental | Drug: SK-1404 |
| SK-1404 low dose | Experimental | Drug: SK-1404 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 5 > nocturnal voids ≥2
- NPI >0.33
Key exclusion criteria (13 listed)
- Polydipsia
- Cardiac failure
- Syndrome of inappropriate antidiuretic hormone secretion
- Hyponatraemia
- Uncontrolled diabetes mellitus
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 |
|---|---|---|
| SK-14044 weeks of repeated administration of SK-1404 to the patients of nocturia | Drug | SK-1404 high dose, SK-1404 low dose, SK-1404 middle dose |
| Placebo4 weeks of repeated administration of Placebo to the patients of nocturia | Drug | Placebo |
Primary outcome
Change from baseline in mean number of nocturnal voids
Time frame: 4 weeks
Assessed by the voiding diary
4 secondary outcomes
Change from base line in mean nocturnal urine volume
Time frame: 4 weeks
Change from base line in mean time to first awakening to void
Time frame: 4 weeks
Change from base line in mean Nocturnal Polyuria Index (NPI)
Time frame: 4 weeks
Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)
Time frame: 4 weeks
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 13 Apr 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SK-1404 in people with Nocturia Due to Nocturnal Polyuria, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
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 13 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 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in mean number of nocturnal voids (time frame: 4 weeks). 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 13 Apr 2018.