Long Term Safety Assessment of SER120 in Patients With Nocturia

This study has been completed.

First Received on September 18, 2009. Last Updated on August 26, 2011 History of Changes

Sponsor:	Serenity Pharmaceuticals, Inc.
Information provided by:	Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00981682

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 III

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:

Estimated Enrollment:	500
Study Start Date:	August 2009
Study Completion Date:	August 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

once a day treatment of nocturia

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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:	Linda Cheng/VP Project Management, Serenity Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00981682 History of Changes
Other Study ID Numbers:	SPC-SER120-OL1-200903
Study First Received:	September 18, 2009
Last Updated:	August 26, 2011
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 February 09, 2012