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OpenTrials
Completed

NCT Number: NCT00981682

Long Term Safety Assessment of SER120 in Patients With Nocturia

The hypothesis of this study is that SER120 is safe and well tolerated for use in 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

50 year–90 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

  • Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
  • Willing to provide consent for the study

Exclusion criteria

  • Incontinence
  • Diabetes Insipidus, Diabetes Mellitus
  • CHF
  • Renal Insufficiency
  • Significant medical history which make participation unacceptable

Treatment and study plan

SER120

Drug

once a day treatment of nocturia

Primary outcomes

  1. Mean Serum Sodium

    Time frame: 40 weeks

    Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline

Sponsors and collaborators

Lead sponsor

Serenity Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase III Open-Label Extension Study to Investigate the Safety of SER120 Nasal Spray Formulations in Patients With Nocturia Completing Study SPC-SER120-DB1-200901 or Study SPC-SER120-DB2-200902

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 22, 2009
Registry last updated
Jan 20, 2021

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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