Treatment of Patients With Nocturia (Non-PK Study)

Nocturia Clinical Trial

Official title:

A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937378
• Other study ID #: SPC-SER120-DB2-200902
• Status: Completed
• Phase: Phase 3
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: April 2014
• Source: Serenity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• SER120
Nasal Spray, once a day
• Placebo
Nasal Spray

Locations

Country	Name	City	State
United States	University Urology Associates	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Serenity Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Number of Nocturic Episodes/Night	Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7	7 weeks
Primary	Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night	Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline	7 weeks