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Completed

NCT Number: NCT01900704

Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

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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–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stephen M. Auerbach, MD

Newport Beach, California, 92660, 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 episodes per night

Exclusion criteria

  • CHF
  • Diabetis Insipidus
  • Renal insufficiency
  • Hepatic insufficiency
  • Incontinence
  • Illnesses 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

Drug

SER120 750 ng

SER120 1500 ng

Drug

SER120 1500 ng

Placebo

Drug

Placebo

Primary outcomes

  1. Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment

    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 Equal of Greater Than 50% Reduction in Mean Nocturic Episodes

    Time frame: 12 weeks

    Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period

Sponsors and collaborators

Lead sponsor

Serenity Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: DB4

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2013
Registry last updated
Nov 9, 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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