NocturiaPhase 3NCT01259128

Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

A Phase 3 study testing SER120 Nasal Spray 500 ng/day and SER120 nasal spray 750 ng/day in people with Nocturia, run by Serenity Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients. Read more about this study

Who is it for?: Ages 75 to 95 years
Conditions the study is for: Nocturia
What is being tested?: SER120 Nasal Spray 500 ng/day and SER120 nasal spray 750 ng/day
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Nov 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 75 to 95 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

Male \& female greater or equal to 75 years of age, history of nocturia

Who cannot join

CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
Unexplained pelvic masses
Urinary bladder surgery or radiotherapy
Sleep apnea

Trial locations and contacts

1 site in 1 country.

United States1 site

Dr. Jolene Berg
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Read the detailed description

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Conditions: Nocturia
Being tested: SER120 Nasal Spray 500 ng/day, SER120 nasal spray 750 ng/day
Medical subject headings: Nocturia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SER120 Nasal Spray 500 ng/dayDrug
SER120 Level 1
SER120 nasal spray 750 ng/dayDrug
SER120 (750 ng/day)

Study groups in NCT01259128
Study group	Role	What they receive
SER120 500 ng/day	Experimental	SER120 Level 1 (500 ng/day) Receives: Drug: SER120 Nasal Spray 500 ng/day
SER120 750 ng/day	Experimental	SER120 Level 2 (750 ng/day) Receives: Drug: SER120 nasal spray 750 ng/day

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Sodium Levels at Baseline and During Treatment
Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.
Measured: baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57

Secondary outcomes (2)

Change in Mean Nocturic Episodes Per Night
Change in mean nocturic episodes per night between baseline and Week 8
Measured: Mean value at Week 8 minus mean value at baseline
Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes
Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Nov 2010

First posted13 Dec 2010 (estimated)
Study startApr 2010
Primary completionNov 2010
Study completionNov 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: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01259128
Sponsor's protocol ID: SPC-SER120-ELD-2010-01
Status last verified: Apr 2014
First submitted: 22 Apr 2010
Last updated: 17 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nocturia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia
ClinicalTrials.gov ID: NCT01259128
Acronym / sponsor ID: SPC-SER120-ELD-2010-01
Conditions: Nocturia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Serenity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 13 Dec 2010 (estimated)
Results: Posted 17 Nov 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 determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Detailed description

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SER120 500 ng/day	Experimental	Drug: SER120 Nasal Spray 500 ng/daySER120 Level 1 (500 ng/day)
SER120 750 ng/day	Experimental	Drug: SER120 nasal spray 750 ng/daySER120 Level 2 (750 ng/day)

Who may qualify

Ages: 75 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

Male \& female greater or equal to 75 years of age, history of nocturia

Key exclusion criteria (4 listed)

CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
Unexplained pelvic masses
Urinary bladder surgery or radiotherapy
Sleep apnea

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 Nasal Spray 500 ng/daySER120 Level 1	Drug	SER120 500 ng/day
SER120 nasal spray 750 ng/daySER120 (750 ng/day)	Drug	SER120 750 ng/day

Primary outcome

Serum Sodium Levels at Baseline and During Treatment
Time frame: baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57
Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.

2 secondary outcomes

Change in Mean Nocturic Episodes Per Night
Time frame: Mean value at Week 8 minus mean value at baseline
Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes
Time frame: 8 weeks

Results and safety

Results posted to the registry on 17 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SER120 500 ng	15	15
SER120 750 ng	17	15

Primary outcome: Serum Sodium Levels at Baseline and During Treatment

Time frame: baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57. Mean (Standard Deviation). Unit: mmol/L

Measure	SER120 500 ng n = 15	SER120 750 ng n = 17
Baseline	141.0 (2.4)	140.0 (1.7)
Day 4	139.2 (3.0)	140.3 (1.3)
Day 8	139.1 (3.2)	140.4 (1.8)
Day 15	140.4 (2.1)	140.2 (1.4)
Day 22	139.5 (3.2)	140.0 (1.4)
Day 29	139.7 (2.7)	139.7 (2.1)
Day 43	139.9 (2.7)	139.6 (1.5)
Day 57	140.9 (2.6)	141.1 (1.7)

Population analysed: Safety population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SER120 500 ng	0 of 15 (0%)	8 of 15 (53.3%)	Not reported
SER120 750 ng	0 of 17 (0%)	12 of 17 (70.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
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APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
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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 Nasal Spray 500 ng/day and SER120 nasal spray 750 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 1 inclusion and 4 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 17 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. 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 17 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?

Serum Sodium Levels at Baseline and During Treatment (time frame: baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01259128.

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 17 Nov 2020.