CompletedNCT00937859Updated Sep 18, 2020Results posted

Treatment of Patients With Nocturia

A Phase 3 interventional study of SER120 and Placebo in Nocturia, sponsored by Serenity Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-09-18.

Sponsored by Serenity Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 301
Allocation: Randomized
Ages: 50 Years and older
Sex: All

Study 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.

Conditions studied

Nocturia

Browse trials for

Nocturia 124

In context

Nocturia

124 studies on the registry are indexed under Nocturia; 24 are open to participants now.

This study's enrollment of 301 is above the median of 67 across 94 interventional studies indexed under Nocturia.

Browse Nocturia studies →

Lead sponsor

Serenity Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male and female 50 years or older
Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion criteria

Exclusion Criteria:

CHF
Diabetes
Diabetes Insipidus
Renal Insufficiency
Hepatic Insufficiency
Incontinence
Illness requiring steroids
Current or past urologic malignancy
Nephrotic Syndrome
Unexplained pelvic masses
Urinary bladder neurological dysfunction
Urinary bladder surgery or radiotherapy
Sleep Apnea
Pregnant or breast feeding

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 301 participants (actual)

Study arms

Experimental
SER120
SER120
Drug: SER120
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugSER120
SER120
DrugPlacebo
Placebo

What researchers measure

Primary outcomes

Change in Mean Number of Nocturic Episodes/Night
Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline
Time frame: 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
Time frame: 7 weeks

Results

Posted Sep 18, 2020

Participant flow

Participant flow — Overall Study
Milestone	SER120	Placebo
Started	148	153
Completed	129	134
Not completed	19	19

Outcome measures

PrimaryChange in Mean Number of Nocturic Episodes/Night

Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline

Time frame:: 7 weeks
Reported as:: Least squares mean · nocturic episodes per night

Change in Mean Number of Nocturic Episodes/Night
nocturic episodes per night	SER120	Placebo
Change in Mean Number of Nocturic Episodes/Night	-1.3 ± 0.9	-1.2 ± 1.0

PrimaryPercent 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

Time frame:: 7 weeks
Reported as:: Count of participants · Participants

Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
Participants	SER120	Placebo
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night	58	58

Adverse events

Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
SER120	—	2/148 (1.4%)	105/148 (70.9%)
Placebo	—	1/153 (0.7%)	108/153 (70.6%)

Most frequent serious events

Most frequent serious events
Event	SER120	Placebo
Arteriosclerosis coronary arteryCardiac disorders	1/148	0/153
breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/148	0/153
mental status changesPsychiatric disorders	0/148	1/153

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	SER120	Placebo
Nasal discomfortRespiratory, thoracic and mediastinal disorders	44/148	58/153
SneezingRespiratory, thoracic and mediastinal disorders	18/148	22/153
RhinorrheaRespiratory, thoracic and mediastinal disorders	13/148	22/153
HeadacheNervous system disorders	6/148	16/153
EpistaxisRespiratory, thoracic and mediastinal disorders	1/148	8/153
NasopharyngitisInfections and infestations	7/148	4/153
Post nasal dripRespiratory, thoracic and mediastinal disorders	7/148	2/153
DiarrheaGastrointestinal disorders	2/148	7/153
DizzinessNervous system disorders	2/148	7/153
Nasal congestionRespiratory, thoracic and mediastinal disorders	5/148	7/153

Baseline characteristics

Intent-to-treat

Age, Continuous
Age, Continuous(years)	SER120	Placebo	Total
Mean	63.8 ± 9.4	63.7 ± 9.6	63.7 ± 9.4

Sex: Female, Male
Sex: Female, Male(Participants)	SER120	Placebo	Total
Female	66	62	128
Male	79	87	166

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	SER120	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	2	8	10
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	19	23	42
White	121	115	236
More than one race	3	3	6
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	SER120	Placebo	Total
United States	145	149	294

Study locations

1 site

Piedmont Medical Research Assoc.
Winston-Salem, North Carolina 27103, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00937859
Lead sponsor: Serenity Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Jul 13, 2009
Start date: Jun 2009
Primary completion: Jul 2010
Completion: Jul 2010
Results posted: Sep 18, 2020
Last update: Sep 18, 2020

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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