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Completed

NCT Number: NCT00937378

Treatment of Patients With Nocturia (Non-PK Study)

The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

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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 3

Primary location

University Urology Associates

New York, 10016, 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 2 episodes or more per night

Exclusion criteria

  • CHF
  • Diabetes
  • Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency
  • Incontinence
  • Illness requiring steroids
  • Current or past urologic malignancy
  • Nephrotic Syndrome
  • Unexplained pelvic masses
  • Urinary bladder neurological dysfunction
  • Urinary bladder surgery or radiotherapy
  • Sleep Apnea
  • Pregnant or breast feeding

Treatment and study plan

SER120

Drug

Nasal Spray, once a day

Placebo

Drug

Nasal Spray

Primary outcomes

  1. Change in Mean Number of Nocturic Episodes/Night

    Time frame: 7 weeks

    Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7

  2. Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night

    Time frame: 7 weeks

    Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline

Sponsors and collaborators

Lead sponsor

Serenity Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2009
Registry last updated
Oct 22, 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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