NocturiaPhase 3NCT00937378
Treatment of Patients With Nocturia (Non-PK Study)
A Phase 3 study testing SER120 in people with Nocturia, run by Serenity Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Nocturia
- What is being tested?
- SER120
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2010
- 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 years and older
- 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 2 episodes or more per night
Who cannot join
- CHF
- Diabetes
- Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency
- Incontinence
- Illness requiring steroids
- Current or past urologic malignancy
Show all 12Show fewer
- Nephrotic Syndrome
- Unexplained pelvic masses
- Urinary bladder neurological dysfunction
- Urinary bladder surgery or radiotherapy
- Sleep Apnea
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University Urology Associates
New York, New York, 10016
About this study
Official title: A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)
The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.
- Conditions
- Nocturia
- Being tested
- SER120, Placebo
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SER120Drug
Nasal Spray, once a day
PlaceboDrug
Nasal Spray
| Study group | Role | What they receive |
|---|---|---|
| SER120 | Experimental | Not described Receives: Drug: SER120 |
| 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 in Mean Number of Nocturic Episodes/Night
Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7
Measured: 7 weeks
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2010
- Study completionAug 2010
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 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
- NCT00937378
- Sponsor's protocol ID
- SPC-SER120-DB2-200902
- Status last verified
- Apr 2014
- First submitted
- 9 Jul 2009
- Last updated
- 22 Oct 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)
- ClinicalTrials.gov ID
- NCT00937378
- Acronym / sponsor ID
- SPC-SER120-DB2-200902
- Conditions
- Nocturia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Serenity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Posted 22 Oct 2020
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 study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SER120 | Experimental | Drug: SER120 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- 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 2 episodes or more per night
Key exclusion criteria (12 listed)
- CHF
- Diabetes
- Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency
- Incontinence
- Illness requiring steroids
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 |
|---|---|---|
| SER120Nasal Spray, once a day | Drug | SER120 |
| PlaceboNasal Spray | Drug | Placebo |
Primary outcome
Change in Mean Number of Nocturic Episodes/Night
Time frame: 7 weeks
Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
Time frame: 7 weeks
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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 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 12 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 22 Oct 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 22 Oct 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?
Change in Mean Number of Nocturic Episodes/Night (time frame: 7 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 22 Oct 2020.