Phase 3
Completed N=326
Treatment of Patients With Nocturia (Non-PK Study)
Nocturia
Source: ClinicalTrials.gov NCT00937378 ↗
Enrolled (actual)
326
Serious AEs
1.2%
Results posted
Oct 2020
Primary outcomePrimary: Change in Mean Number of Nocturic Episodes/Night — -1.3; -1.2 nocturic episodes per night
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
83; 64 | — |
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 (NCT00937378). 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. Informational only — not medical advice.