Long Term Safety Assessment of SER120 in Patients With Nocturia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00981682
First received: September 18, 2009
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Nocturia
Drug: SER120
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Open-Label Extension Study to Investigate the Safety of SER120 Nasal Spray Formulations in Patients With Nocturia Completing Study SPC-SER120-DB1-200901 or Study SPC-SER120-DB2-200902

Further study details as provided by Serenity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • safety evaluation of SER120 in terms of laboratory and clinical assessments [ Time Frame: 11 month study ] [ Designated as safety issue: Yes ]

Enrollment: 376
Study Start Date: August 2009
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SER120 (desmopressin) Drug: SER120
once a day treatment of nocturia

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981682

Locations
United States, California
Stephen M. Auerbach, MD
Newport Beach, California, United States, 92660
Sponsors and Collaborators
Serenity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00981682     History of Changes
Other Study ID Numbers: SPC-SER120-OL1-200903
Study First Received: September 18, 2009
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Serenity Pharmaceuticals, Inc.:
decrease in the number of nocturic episodes for patients with nocturia

Additional relevant MeSH terms:
Nocturia
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014