Treatment of Patients With Nocturia
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
1 other identifier
interventional
301
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 9, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
September 18, 2020
CompletedSeptember 18, 2020
April 1, 2014
1.1 years
July 9, 2009
August 28, 2020
August 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Mean Number of Nocturic Episodes/Night
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
7 weeks
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
7 weeks
Study Arms (2)
SER120
EXPERIMENTALSER120
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and female 50 years or older
- Nocturia of 6 or more months duration averaging 2 episodes or more per night
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Piedmont Medical Research Assoc.
Winston-Salem, North Carolina, 27103, 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2009
First Posted
July 13, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
September 18, 2020
Results First Posted
September 18, 2020
Record last verified: 2014-04