Status:
COMPLETED
Treatment of Patients With Nocturia (Non-PK Study)
Lead Sponsor:
Serenity Pharmaceuticals, Inc.
Conditions:
Nocturia
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Male and Female 50 years or older
- Nocturia of 6 or more months duration averaging 2 episodes or more per night
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00937378
Start Date
June 1 2009
End Date
August 1 2010
Last Update
October 22 2020
Active Locations (1)
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1
University Urology Associates
New York, New York, United States, 10016