Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia
1 other identifier
interventional
750
1 country
1
Brief Summary
The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Typical duration for phase_2
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
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
October 8, 2020
CompletedOctober 8, 2020
November 1, 2015
1.4 years
May 18, 2011
August 25, 2020
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in # of Mean Nocturic Episodes Per Night
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
12 weeks
Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes
Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline
12 weeks
Study Arms (4)
SER120 (750 ng/day)
EXPERIMENTALSER120 (750 ng/day)
SER120 (1000 ng/day)
EXPERIMENTALSER120 (1000 ng/day)
SER120 (1500 ng/day)
EXPERIMENTALSER120 (1500 ng/day)
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 episode per night
You may not qualify if:
- CHF
- Diabetis Insipidus
- Renal Insufficiency
- Hepatic Insufficiency
- Incontinence
- Illness 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)
Serenity R&D
New City, New York, 10956, 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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 20, 2011
Study Start
May 1, 2011
Primary Completion
October 1, 2012
Study Completion
December 1, 2014
Last Updated
October 8, 2020
Results First Posted
October 8, 2020
Record last verified: 2015-11