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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01357356
First received: May 18, 2011
Last updated: March 5, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • # of nights with zero nocturic episode [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: May 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01357356

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

No publications provided

Responsible Party: Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01357356     History of Changes
Other Study ID Numbers: SPC-SER120-DB3-201101
Study First Received: May 18, 2011
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014