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OpenTrials
Completed

NCT Number: NCT01357356

Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia

The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Serenity R&D

New City, New York, 10956, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female 50 years or older
  • Nocturia of 6 or more months duration averaging greater than 2 nocturic episode per night

Exclusion criteria

  • CHF
  • Diabetis Insipidus
  • Renal Insufficiency
  • Hepatic Insufficiency
  • Incontinence
  • Illness requiring systemic steroids
  • Malignancy within the past 5 years
  • Sleep Apnea
  • Nephrotic Syndrome
  • Unexplained Pelvic Mass
  • Urinary Bladder Neurological dysfunction
  • Urinary Bladder Surgery or Radiotherapy
  • Pregnant or Breast Feeding

Treatment and study plan

SER120 (750 ng/day)

Drug

SER120 (1000 ng/day)

Drug

SER120 (1000 ng/day)

SER120 (1500 ng/day)

Drug

Placebo

Drug

Primary outcomes

  1. Change in # of Mean Nocturic Episodes Per Night

    Time frame: 12 weeks

    Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12

  2. Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes

    Time frame: 12 weeks

    Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline

Sponsors and collaborators

Lead sponsor

Serenity Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
May 20, 2011
Registry last updated
Oct 8, 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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