Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01259128
First received: April 22, 2010
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.


Condition Intervention Phase
Nocturia
Drug: SER120 Nasal Spray Level 1
Drug: SER120 (750 ng/day)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia

Further study details as provided by Serenity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of SER120 nasal spray in 75 years or older nocturic patients in terms of serum sodium levels and adverse events. [ Time Frame: up to 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: April 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SER120 Level 1
SER120 Level 1 (500 ng/day)
Drug: SER120 Nasal Spray Level 1
SER120 Level 1
Experimental: SER120 Level 2
SER120 Level 2 (750 ng/day)
Drug: SER120 (750 ng/day)
SER120 (750 ng/day)

Detailed Description:

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

  Eligibility

Ages Eligible for Study:   75 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male & female greater or equal to 75 years of age, history of nocturia

Exclusion Criteria:

  • CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
  • Unexplained pelvic masses
  • Urinary bladder surgery or radiotherapy
  • Sleep apnea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259128

Locations
United States, Texas
Dr. Jolene Berg
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Serenity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01259128     History of Changes
Other Study ID Numbers: SPC-SER120-ELD-2010-01
Study First Received: April 22, 2010
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nocturia
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014