NCT00981682

Brief Summary

The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
376

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2009

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

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

January 20, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

September 18, 2009

Results QC Date

December 23, 2020

Last Update Submit

December 23, 2020

Conditions

Nocturia

Keywords

decrease in the number of nocturic episodes for patients with nocturia

Outcome Measures

Primary Outcomes (1)

  • Mean Serum Sodium

    Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline

    40 weeks

Study Arms (1)

SER120 (desmopressin)

EXPERIMENTAL
Drug: SER120

Interventions

SER120DRUG

once a day treatment of nocturia

SER120 (desmopressin)

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
  • Willing to provide consent for the study

You may not qualify if:

  • Incontinence
  • Diabetes Insipidus, Diabetes Mellitus
  • CHF
  • Renal Insufficiency
  • Significant medical history which make participation unacceptable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephen M. Auerbach, MD

Newport Beach, California, 92660, 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
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 22, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

January 20, 2021

Results First Posted

January 20, 2021

Record last verified: 2014-01

Locations

US(1)