Phase 3 N=32 Randomized Treatment

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

Nocturia

Bottom Line

View on ClinicalTrials.gov: NCT01259128 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Serum Sodium Levels at Baseline and During Treatment — 141.0; 140.0; 139.2; 140.3 mmol/L

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: SER120 Nasal Spray 500 ng/day (Drug); SER120 nasal spray 750 ng/day (Drug)
Age: Older Adult · 75+ yrs
Sex: All
Sponsor: Serenity Pharmaceuticals, Inc.
Primary completion: Nov 2010

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	—

Summary

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

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

View full record on ClinicalTrials.gov →

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.