We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357356
First Posted: May 20, 2011
Last Update Posted: December 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc.
  Purpose
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
Nocturia 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 (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
Placebo
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357356


Locations
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.
ClinicalTrials.gov Identifier: NCT01357356     History of Changes
Other Study ID Numbers: SPC-SER120-DB3-201101
First Submitted: May 18, 2011
First Posted: May 20, 2011
Last Update Posted: December 24, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms