Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

Serenity Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Nocturia

Treatments: Drug: SER120 750 ng; Drug: Placebo; Drug: SER120 1500 ng

Study type: Interventional

Funder types: Industry

Identifiers

NCT01900704

SPC-SER120-DB4-201301

Details and patient eligibility

About

To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Enrollment: 810 patients

Sex: All

Ages: 50 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female 50 years or older
• Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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810 participants in 3 patient groups, including a placebo group

SER120 750 ng

Experimental group

Description:

SER120 750 ng

Treatment:

Drug: SER120 750 ng

SER120 1500 ng

Experimental group

Description:

SER120 1500 ng

Treatment:

Drug: SER120 1500 ng

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo