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: April 24, 2014
Last verified: April 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 500 ng/day
Drug: SER120 nasal spray 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 500 ng/day
SER120 Level 1 (500 ng/day)
Drug: SER120 Nasal Spray 500 ng/day
SER120 Level 1
Experimental: SER120 750 ng/day
SER120 Level 2 (750 ng/day)
Drug: SER120 nasal spray 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014