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Treatment of Patients With Nocturia

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. Identifier: NCT00937859
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Nocturia Drug: SER120 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: SER120
Drug: SER120

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Change in Mean Number of Nocturic Episodes/Night [ Time Frame: 7 weeks ]
    Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline

  2. Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night [ Time Frame: 7 weeks ]
    Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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 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

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 identifier (NCT number): NCT00937859

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United States, North Carolina
Piedmont Medical Research Assoc.
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Serenity Pharmaceuticals, Inc.
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Responsible Party: Serenity Pharmaceuticals, Inc. Identifier: NCT00937859    
Other Study ID Numbers: SPC-SER120-DB1-200901
First Posted: July 13, 2009    Key Record Dates
Results First Posted: September 18, 2020
Last Update Posted: September 18, 2020
Last Verified: April 2014
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations