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Treatment of Patients With Nocturia (Non-PK Study)

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: NCT00937378
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : October 22, 2020
Last Update Posted : October 22, 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 : 326 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 the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)
Study Start Date : June 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: SER120 Drug: SER120
Nasal Spray, once a day

Placebo Comparator: Placebo Drug: Placebo
Nasal Spray

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 between baseline and Week 7

  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): NCT00937378

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United States, New York
University Urology Associates
New York, New York, United States, 10016
Sponsors and Collaborators
Serenity Pharmaceuticals, Inc.
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Responsible Party: Serenity Pharmaceuticals, Inc. Identifier: NCT00937378    
Other Study ID Numbers: SPC-SER120-DB2-200902
First Posted: July 13, 2009    Key Record Dates
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020
Last Verified: April 2014
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations