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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Long Term Safety Assessment of SER120 in Patients With Nocturia

NCTNCT00981682 (opens ClinicalTrials.gov in a new tab)Other idSPC-SER120-OL1-200903
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
376 participants (actual)
Sponsor
Serenity Pharmaceuticals, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Aug 2009
Primary completion
Jun 2011
Completion
Aug 2011
First posted
22 Sept 2009 (estimated)
Last update posted
20 Jan 2021
Conditions
Nocturia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 3

    Long Term Safety Assessment of SER120 in Patients With Nocturia

    NCT00981682

    Aug 2009 to Aug 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • SER120Drug

Arms1

  • Experimental

    SER120 (desmopressin)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Serum Sodium

    Time frame · 40 weeks

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 40 weeks

Mean Serum Sodium

GroupValue (mmol/L)Spread
SER120 750 mcg-0.02.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SER120 750 mcgAll participants received up to 750 mcg SER120 once daily30 / 37630 / 376305 / 376

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies * Willing to provide consent for the study Exclusion Criteria: * Incontinence * Diabetes Insipidus, Diabetes Mellitus * CHF * Renal Insufficiency * Significant medical history which make participation unacceptable

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