Phase 3
Completed N=32
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Nocturia
Source: ClinicalTrials.gov NCT01259128 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Serum Sodium Levels at Baseline and During Treatment — 141.0; 140.0; 139.2; 140.3 mmol/L
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Sodium Levels at Baseline and During Treatment |
141.0; 140.0; 139.2; 140.3; 139.1; 140.4 | — |
| SECONDARY Change in Mean Nocturic Episodes Per Night |
-1.5; -1.4 | — |
| SECONDARY Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes |
11; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Male & female greater or equal to 75 years of age, history of nocturia
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01259128). 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.