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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Nocturia

In brief

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.

Key facts

Study ID

NCT01357356

Run by

Serenity Pharmaceuticals, Inc.

People needed

750

Starts

2011-05-01

Expected to finish

2014-12-01

Last updated by the study team

2020-10-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Serenity R&D — New City, New York, United States

Full record on ClinicalTrials.gov

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