NocturiaPhase 3DB4NCT01900704
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
A Phase 3 study testing SER120 750 ng and SER120 1500 ng in people with Nocturia, run by Serenity Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Nocturia
- What is being tested?
- SER120 750 ng and SER120 1500 ng
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 810 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female 50 years or older
- Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night
Who cannot join
- CHF
- Diabetis Insipidus
- Renal insufficiency
- Hepatic insufficiency
- Incontinence
- Illnesses requiring systemic steroids
Show all 13Show fewer
- Malignancy within the past 5 years
- Sleep apnea
- Nephrotic syndrome
- Unexplained pelvic mass
- Urinary bladder neurological dysfunction
- Urinary bladder surgery or radiotherapy
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephen M. Auerbach, MD
Newport Beach, California, 92660
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia
- Conditions
- Nocturia
- Being tested
- SER120 750 ng, SER120 1500 ng, Placebo
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SER120 750 ngDrug
SER120 750 ng
SER120 1500 ngDrug
SER120 1500 ng
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SER120 750 ng | Experimental | SER120 750 ng Receives: Drug: SER120 750 ng |
| SER120 1500 ng | Experimental | SER120 1500 ng Receives: Drug: SER120 1500 ng |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Measured: 12 weeks
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes
Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NocturiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serenity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900704
- Sponsor's protocol ID
- SPC-SER120-DB4-201301
- Acronym
- DB4
- Status last verified
- Nov 2015
- First submitted
- 12 Jul 2013
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
- ClinicalTrials.gov ID
- NCT01900704
- Acronym / sponsor ID
- DB4 / SPC-SER120-DB4-201301
- Conditions
- Nocturia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Serenity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Posted 9 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SER120 750 ng | Experimental | Drug: SER120 750 ngSER120 750 ng |
| SER120 1500 ng | Experimental | Drug: SER120 1500 ngSER120 1500 ng |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female 50 years or older
- Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night
Key exclusion criteria (13 listed)
- CHF
- Diabetis Insipidus
- Renal insufficiency
- Hepatic insufficiency
- Incontinence
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 |
|---|---|---|
| SER120 750 ngSER120 750 ng | Drug | SER120 750 ng |
| SER120 1500 ngSER120 1500 ng | Drug | SER120 1500 ng |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment
Time frame: 12 weeks
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes
Time frame: 12 weeks
Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 3 study testing SER120 750 ng and SER120 1500 ng in people with Nocturia, run by Serenity Pharmaceuticals, Inc. at 1 site in United States.
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 9 Nov 2020. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 9 Nov 2020.