Last updated on August 2011

A randomized, double, placebo-controlled, parallel group study to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia.


Brief description of study

A randomized, double, placebo-controlled, parallel group study to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia.

Detailed Study Description

SER120 will be administered intra-nasally as a single spray in either the left or right nostril each night before bedtime. The placebo will also be administered this same way.

Inclusions

  • Male or female > 50 years of age
  • Documented nocturia > 2 nocturic episodes/night for at least 6 months by history

Exclusions:

  • Obstructive sleep apnea
  • Evidence of current UTI, bladder stone, bladder pain syndrome, or I.C.
  • History of urinary bladder surgery or radiotherapy within the last 24 months prior to enrollment
  • Severe daytime LUTS secondary to benign prostatic hypertrophy, OAB, or severe stress urinary incontinence

Clinical Study Identifier: TX135437

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Debbie Johnson, CCRC

First Urology, PSC
Jeffersonville, IN USA
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