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

NCT ID: NCT01259128

Last Updated: 2020-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Nocturia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SER120 500 ng/day

SER120 Level 1 (500 ng/day)

Group Type EXPERIMENTAL

SER120 Nasal Spray 500 ng/day

Intervention Type DRUG

SER120 Level 1

SER120 750 ng/day

SER120 Level 2 (750 ng/day)

Group Type EXPERIMENTAL

SER120 nasal spray 750 ng/day

Intervention Type DRUG

SER120 (750 ng/day)

Interventions

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SER120 Nasal Spray 500 ng/day

SER120 Level 1

Intervention Type DRUG

SER120 nasal spray 750 ng/day

SER120 (750 ng/day)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Serenity Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr. Jolene Berg

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SPC-SER120-ELD-2010-01

Identifier Type: -

Identifier Source: org_study_id