Long Term Safety Assessment of SER120 in Patients With Nocturia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00981682
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : February 28, 2014
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Nocturia Drug: SER120 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: SER120 (desmopressin) Drug: SER120
once a day treatment of nocturia

Primary Outcome Measures :
  1. safety evaluation of SER120 in terms of laboratory and clinical assessments [ Time Frame: 11 month study ]

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00981682

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

Responsible Party: Serenity Pharmaceuticals, Inc. Identifier: NCT00981682     History of Changes
Other Study ID Numbers: SPC-SER120-OL1-200903
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms