Phase 3
N=301
Treatment of Patients With Nocturia
Nocturia
Bottom Line
View on ClinicalTrials.gov: NCT00937859 ↗Enrolled (actual)
301
Serious AEs
1.0%
Results posted
Sep 2020
Primary outcome: Primary: Change in Mean Number of Nocturic Episodes/Night — -1.3; -1.2 nocturic episodes per night
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SER120 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Serenity Pharmaceuticals, Inc.
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Number of Nocturic Episodes/Night |
-1.3; -1.2 | — |
| PRIMARY Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night |
58; 58 | — |
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.
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT00937859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.