NocturiaPhase 2/3NCT01357356
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia
A Phase 2/3 study testing SER120 (750 ng/day), SER120 (1000 ng/day) and SER120 (1500 ng/day) in people with Nocturia, run by Serenity Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks. 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 (750 ng/day), SER120 (1000 ng/day) and SER120 (1500 ng/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2014
- Phase
- Phase 2/3
- 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 greater than 2 nocturic episode per night
Who cannot join
- CHF
- Diabetis Insipidus
- Renal Insufficiency
- Hepatic Insufficiency
- Incontinence
- Illness requiring systemic steroids
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- 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.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia
The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.
- Conditions
- Nocturia
- Being tested
- SER120 (750 ng/day), SER120 (1000 ng/day), SER120 (1500 ng/day), 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 ng/day)Drug
SER120 (1000 ng/day)Drug
SER120 (1000 ng/day)
SER120 (1500 ng/day)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SER120 (750 ng/day) | Experimental | SER120 (750 ng/day) Receives: Drug: SER120 (750 ng/day) |
| SER120 (1000 ng/day) | Experimental | SER120 (1000 ng/day) Receives: Drug: SER120 (1000 ng/day) |
| SER120 (1500 ng/day) | Experimental | SER120 (1500 ng/day) Receives: Drug: SER120 (1500 ng/day) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in # of Mean Nocturic Episodes Per Night
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 50% or Greater in Reduction of Nocturic Episodes
Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline
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 posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2012
- Study completionDec 2014
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 750 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
- NCT01357356
- Sponsor's protocol ID
- SPC-SER120-DB3-201101
- Status last verified
- Nov 2015
- First submitted
- 18 May 2011
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia
- ClinicalTrials.gov ID
- NCT01357356
- Acronym / sponsor ID
- SPC-SER120-DB3-201101
- Conditions
- Nocturia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Serenity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Posted 8 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 investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SER120 (750 ng/day) | Experimental | Drug: SER120 (750 ng/day)SER120 (750 ng/day) |
| SER120 (1000 ng/day) | Experimental | Drug: SER120 (1000 ng/day)SER120 (1000 ng/day) |
| SER120 (1500 ng/day) | Experimental | Drug: SER120 (1500 ng/day)SER120 (1500 ng/day) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
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 greater than 2 nocturic episode 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 ng/day) | Drug | SER120 (750 ng/day) |
| SER120 (1000 ng/day)SER120 (1000 ng/day) | Drug | SER120 (1000 ng/day) |
| SER120 (1500 ng/day) | Drug | SER120 (1500 ng/day) |
| Placebo | Drug | Placebo |
Primary outcome
Change in # of Mean Nocturic Episodes Per Night
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 50% or Greater in Reduction of Nocturic Episodes
Time frame: 12 weeks
Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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 2/3 study testing SER120 (750 ng/day), SER120 (1000 ng/day) and SER120 (1500 ng/day) 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 8 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 combined 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.
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 8 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 # of Mean Nocturic Episodes Per Night (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 8 Oct 2020.