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Treatment of Patients With Nocturia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937859
First Posted: July 13, 2009
Last Update Posted: May 13, 2014
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 evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Condition Intervention Phase
Nocturia Drug: SER120 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia

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

Primary Outcome Measures:
  • number of nocturic episodes [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • proportion of nights with less than or equal to one nocturic episode [ Time Frame: 4 weeks ]

Enrollment: 301
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SER120
SER120
Drug: SER120
SER120
Placebo Comparator: Placebo Drug: Placebo
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 2 episodes or more per night

Exclusion Criteria:

  • CHF
  • Diabetes
  • Diabetes Insipidus
  • Renal Insufficiency
  • Hepatic Insufficiency
  • Incontinence
  • Illness requiring steroids
  • Current or past urologic malignancy
  • Nephrotic Syndrome
  • Unexplained pelvic masses
  • Urinary bladder neurological dysfunction
  • Urinary bladder surgery or radiotherapy
  • Sleep Apnea
  • 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): NCT00937859


Locations
United States, North Carolina
Piedmont Medical Research Assoc.
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Serenity Pharmaceuticals, Inc.
  More Information

Responsible Party: Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00937859     History of Changes
Other Study ID Numbers: SPC-SER120-DB1-200901
First Submitted: July 9, 2009
First Posted: July 13, 2009
Last Update Posted: May 13, 2014
Last Verified: April 2014

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