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OpenTrials
Completed

NCT Number: NCT01259128

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

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

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Key information

Conditions

Nocturia Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

75 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Jolene Berg

San Antonio, Texas, 78229, United States

About this study

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SER120 Nasal Spray 500 ng/day

Drug

SER120 Level 1

SER120 nasal spray 750 ng/day

Drug

SER120 (750 ng/day)

Primary outcomes

  1. Serum Sodium Levels at Baseline and During Treatment

    Time frame: baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57

    Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.

Secondary outcomes

  1. Change in Mean Nocturic Episodes Per Night

    Time frame: Mean value at Week 8 minus mean value at baseline

    Change in mean nocturic episodes per night between baseline and Week 8

  2. Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes

    Time frame: 8 weeks

    Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline

Sponsors and collaborators

Lead sponsor

Serenity Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 13, 2010
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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