Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

Serenity Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Nocturia

Treatments: Drug: SER120 Nasal Spray 500 ng/day; Drug: SER120 nasal spray 750 ng/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT01259128

SPC-SER120-ELD-2010-01

Details and patient eligibility

About

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Full description

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Enrollment: 32 patients

Sex: All

Ages: 75 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male & female greater or equal to 75 years of age, history of nocturia

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

SER120 500 ng/day

Experimental group

Description:

SER120 Level 1 (500 ng/day)

Treatment:

Drug: SER120 Nasal Spray 500 ng/day

SER120 750 ng/day

Experimental group

Description:

SER120 Level 2 (750 ng/day)

Treatment:

Drug: SER120 nasal spray 750 ng/day