Status:
COMPLETED
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
Lead Sponsor:
Serenity Pharmaceuticals, Inc.
Conditions:
Nocturia
Eligibility:
All Genders
50-95 years
Phase:
PHASE3
Brief Summary
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia
Eligibility Criteria
Inclusion
- Male and female 50 years or older
- Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT01900704
Start Date
August 1 2013
End Date
April 1 2015
Last Update
November 9 2020
Active Locations (1)
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1
Stephen M. Auerbach, MD
Newport Beach, California, United States, 92660