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

This study has been completed.
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc. Identifier:
First received: May 18, 2011
Last updated: November 23, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Drug: SER120 (750 ng/day)
Drug: SER120 (1000 ng/day)
Drug: SER120 (1500 ng/day)
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia

Further study details as provided by Serenity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • # of nocturic episodes during treatment compare to baseline [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • # of nights with zero nocturic episode [ Time Frame: 3 months ]

Enrollment: 816
Study Start Date: May 2011
Study Completion Date: December 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SER120 (750 ng/day)
SER120 (750 ng/day)
Drug: SER120 (750 ng/day)
Experimental: SER120 (1000 ng/day)
SER120 (1000 ng/day)
Drug: SER120 (1000 ng/day)
SER120 (1000 ng/day)
Experimental: SER120 (1500 ng/day)
SER120 (1500 ng/day)
Drug: SER120 (1500 ng/day)
Placebo Comparator: Placebo
Drug: Placebo


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01357356

United States, New York
Serenity R&D
New City, New York, United States, 10956
Sponsors and Collaborators
Serenity Pharmaceuticals, Inc.
  More Information

Responsible Party: Serenity Pharmaceuticals, Inc. Identifier: NCT01357356     History of Changes
Other Study ID Numbers: SPC-SER120-DB3-201101
Study First Received: May 18, 2011
Last Updated: November 23, 2015

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms processed this record on April 28, 2017