Treatment of Patients With Nocturia (Non-PK Study)

Serenity Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Nocturia

Treatments: Drug: SER120; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00937378

SPC-SER120-DB2-200902

Details and patient eligibility

About

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.

Enrollment: 326 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and Female 50 years or older
• Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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326 participants in 2 patient groups, including a placebo group

SER120

Experimental group

Treatment:

Drug: SER120

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo