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Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

NCT ID: NCT01900704

Last Updated: 2020-11-09

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

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-04-30

Brief Summary

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To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Detailed Description

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Conditions

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Nocturia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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SER120 750 ng

SER120 750 ng

Group Type EXPERIMENTAL

SER120 750 ng

Intervention Type DRUG

SER120 750 ng

SER120 1500 ng

SER120 1500 ng

Group Type EXPERIMENTAL

SER120 1500 ng

Intervention Type DRUG

SER120 1500 ng

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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SER120 750 ng

SER120 750 ng

Intervention Type DRUG

SER120 1500 ng

SER120 1500 ng

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female 50 years or older
* Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night

Exclusion Criteria

* CHF
* Diabetis Insipidus
* Renal insufficiency
* Hepatic insufficiency
* Incontinence
* Illnesses requiring systemic steroids
* Malignancy within the past 5 years
* Sleep apnea
* Nephrotic syndrome
* Unexplained pelvic mass
* Urinary bladder neurological dysfunction
* Urinary bladder surgery or radiotherapy
* Pregnant or breast feeding
Minimum Eligible Age

50 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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Stephen M. Auerbach, MD

Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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SPC-SER120-DB4-201301

Identifier Type: -

Identifier Source: org_study_id