Status:
COMPLETED
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Lead Sponsor:
Serenity Pharmaceuticals, Inc.
Conditions:
Nocturia
Eligibility:
All Genders
75-95 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.
Detailed Description
Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration
Eligibility Criteria
Inclusion
- Male \& female greater or equal to 75 years of age, history of nocturia
Exclusion
- CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
- Unexplained pelvic masses
- Urinary bladder surgery or radiotherapy
- Sleep apnea
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01259128
Start Date
April 1 2010
End Date
November 1 2010
Last Update
November 17 2020
Active Locations (1)
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1
Dr. Jolene Berg
San Antonio, Texas, United States, 78229