Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
DB4
A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
1 other identifier
interventional
810
1 country
1
Brief Summary
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
November 9, 2020
CompletedNovember 9, 2020
November 1, 2015
1.7 years
July 12, 2013
August 25, 2020
November 6, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
12 weeks
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes
Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period
12 weeks
Study Arms (3)
SER120 750 ng
EXPERIMENTALSER120 750 ng
SER120 1500 ng
EXPERIMENTALSER120 1500 ng
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Male and female 50 years or older
- Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stephen M. Auerbach, MD
Newport Beach, California, 92660, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Serenity Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 16, 2013
Study Start
August 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
November 9, 2020
Results First Posted
November 9, 2020
Record last verified: 2015-11