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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014