Back to resultsStudy to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Primary Purpose
Nocturia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SER120 Nasal Spray 500 ng/day
SER120 nasal spray 750 ng/day
Sponsored by
About this trial
This is an interventional treatment trial for Nocturia
Eligibility Criteria
Inclusion Criteria:
- Male & female greater or equal to 75 years of age, history of nocturia
Exclusion Criteria:
- CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
- Unexplained pelvic masses
- Urinary bladder surgery or radiotherapy
- Sleep apnea
Sites / Locations
- Dr. Jolene Berg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SER120 500 ng/day
SER120 750 ng/day
Arm Description
SER120 Level 1 (500 ng/day)
SER120 Level 2 (750 ng/day)
Outcomes
Primary Outcome Measures
Serum Sodium Levels at Baseline and During Treatment
Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.
Secondary Outcome Measures
Change in Mean Nocturic Episodes Per Night
Change in mean nocturic episodes per night between baseline and Week 8
Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes
Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline
Full Information
NCT ID
NCT01259128
First Posted
April 22, 2010
Last Updated
November 6, 2020
Sponsor
Serenity Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01259128
Brief Title
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Official Title
A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serenity Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.
Detailed Description
Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SER120 500 ng/day
Arm Type
Experimental
Arm Description
SER120 Level 1 (500 ng/day)
Arm Title
SER120 750 ng/day
Arm Type
Experimental
Arm Description
SER120 Level 2 (750 ng/day)
Intervention Type
Drug
Intervention Name(s)
SER120 Nasal Spray 500 ng/day
Intervention Description
SER120 Level 1
Intervention Type
Drug
Intervention Name(s)
SER120 nasal spray 750 ng/day
Intervention Description
SER120 (750 ng/day)
Primary Outcome Measure Information:
Title
Serum Sodium Levels at Baseline and During Treatment
Description
Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.
Time Frame
baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57
Secondary Outcome Measure Information:
Title
Change in Mean Nocturic Episodes Per Night
Description
Change in mean nocturic episodes per night between baseline and Week 8
Time Frame
Mean value at Week 8 minus mean value at baseline
Title
Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes
Description
Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male & female greater or equal to 75 years of age, history of nocturia
Exclusion Criteria:
CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
Unexplained pelvic masses
Urinary bladder surgery or radiotherapy
Sleep apnea
Facility Information:
Facility Name
Dr. Jolene Berg
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
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