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Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4 (DB4)

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ClinicalTrials.gov Identifier: NCT01900704
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc.

Brief Summary:
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Condition or disease Intervention/treatment Phase
Nocturia Drug: SER120 750 ng Drug: SER120 1500 ng Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
Study Start Date : August 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: SER120 750 ng
SER120 750 ng
Drug: SER120 750 ng
SER120 750 ng

Experimental: SER120 1500 ng
SER120 1500 ng
Drug: SER120 1500 ng
SER120 1500 ng

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment [ Time Frame: 12 weeks ]
    Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12

  2. Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes [ Time Frame: 12 weeks ]
    Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period

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Ages Eligible for Study:   50 Years to 95 Years   (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 greater than 2 nocturic episodes per night

Exclusion Criteria:

  • CHF
  • Diabetis Insipidus
  • Renal insufficiency
  • Hepatic insufficiency
  • Incontinence
  • Illnesses 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

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): NCT01900704

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United States, California
Stephen M. Auerbach, MD
Newport Beach, California, United States, 92660
Sponsors and Collaborators
Serenity Pharmaceuticals, Inc.
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Responsible Party: Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01900704    
Other Study ID Numbers: SPC-SER120-DB4-201301
First Posted: July 16, 2013    Key Record Dates
Results First Posted: November 9, 2020
Last Update Posted: November 9, 2020
Last Verified: November 2015
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations