Treatment of Patients With Nocturia

This study has been completed.

Sponsor:

Information provided by:

Serenity Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00937859

First received: July 9, 2009

Last updated: December 8, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 9, 2009
Last Updated Date	December 8, 2010
Start Date ^ICMJE	June 2009
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 10, 2009)	number of nocturic episodes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00937859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 10, 2009)	proportion of nights with less than or equal to one nocturic episode [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Treatment of Patients With Nocturia
Official Title ^ICMJE	A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
Brief Summary	The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Nocturia
Intervention ^ICMJE	Drug: SER120 nasal spray, once per day
Study Arm (s)	Experimental: SER120 Intervention: Drug: SER120
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	301
Completion Date	July 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male and female 50 years or older Nocturia of 6 or more months duration averaging 2 episodes or more per night Exclusion Criteria: CHF Diabetes Diabetes Insipidus Renal Insufficiency Hepatic Insufficiency Incontinence Illness requiring steroids Current or past urologic malignancy Nephrotic Syndrome Unexplained pelvic masses Urinary bladder neurological dysfunction Urinary bladder surgery or radiotherapy Sleep Apnea Pregnant or breast feeding
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00937859
Other Study ID Numbers ^ICMJE	SPC-SER120-DB1-200901
Has Data Monitoring Committee	No
Responsible Party	Linda Cheng, Serenity Pharmaceuticals, LLC
Study Sponsor ^ICMJE	Serenity Pharmaceuticals, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Serenity Pharmaceuticals, Inc.
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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