NCT01259128

Brief Summary

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

November 17, 2020

Completed
Last Updated

November 17, 2020

Status Verified

April 1, 2014

Enrollment Period

7 months

First QC Date

April 22, 2010

Results QC Date

October 7, 2020

Last Update Submit

November 6, 2020

Conditions

Nocturia

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57

Secondary Outcomes (2)

  • Change in Mean Nocturic Episodes Per Night

    Mean value at Week 8 minus mean value at baseline

  • Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes

    8 weeks

Study Arms (2)

SER120 500 ng/day

EXPERIMENTAL

SER120 Level 1 (500 ng/day)

Drug: SER120 Nasal Spray 500 ng/day

SER120 750 ng/day

EXPERIMENTAL

SER120 Level 2 (750 ng/day)

Drug: SER120 nasal spray 750 ng/day

Interventions

SER120 Nasal Spray 500 ng/dayDRUG

SER120 Level 1

SER120 500 ng/day
SER120 nasal spray 750 ng/dayDRUG

SER120 (750 ng/day)

SER120 750 ng/day

Eligibility Criteria

Age75 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male \& female greater or equal to 75 years of age, history of nocturia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Jolene Berg

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Chief Medical Officer
Organization
Serenity Pharmaceuticals
sfein@serenitypharma.com
8456396760

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2010

First Posted

December 13, 2010

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 17, 2020

Results First Posted

November 17, 2020

Record last verified: 2014-04

Locations

US(1)