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

Serenity Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nocturia

Treatments: Drug: SER120 (1000 ng/day); Drug: SER120 (1500 ng/day); Drug: Placebo; Drug: SER120 (750 ng/day)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01357356

SPC-SER120-DB3-201101

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.

Enrollment: 750 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 greater than 2 nocturic episode per night

Exclusion criteria

• CHF
• Diabetis Insipidus
• Renal Insufficiency
• Hepatic Insufficiency
• Incontinence
• Illness 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: Double Blind

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750 participants in 4 patient groups, including a placebo group

SER120 (750 ng/day)

Experimental group

Description:

SER120 (750 ng/day)

Treatment:

Drug: SER120 (750 ng/day)

SER120 (1000 ng/day)

Experimental group

Description:

SER120 (1000 ng/day)

Treatment:

Drug: SER120 (1000 ng/day)

SER120 (1500 ng/day)

Experimental group

Description:

SER120 (1500 ng/day)

Treatment:

Drug: SER120 (1500 ng/day)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo