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Dose Ranging Study

NCT ID: NCT01802723

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-10-31

Brief Summary

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Dose Ranging Study

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Detailed Description

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Conditions

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Periumbilical Subcutaneous Adipose Tissue Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LIPO-202, Low

Drug: salmeterol xinafoate

Group Type EXPERIMENTAL

Drug: salmeterol xinafoate

Intervention Type DRUG

LIPO-202, Mid

Drug: salmeterol xinafoate

Group Type EXPERIMENTAL

Drug: salmeterol xinafoate

Intervention Type DRUG

LIPO-202, High

Drug: salmeterol xinafoate

Group Type EXPERIMENTAL

Drug: salmeterol xinafoate

Intervention Type DRUG

LIPO-202, Placebo

Drug: Placebo

Group Type EXPERIMENTAL

Drug: Placebo

Intervention Type DRUG

Interventions

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Drug: salmeterol xinafoate

Intervention Type DRUG

Drug: Placebo

Intervention Type DRUG

Other Intervention Names

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LIPO-202 Salmeterol Placebo

Eligibility Criteria

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Inclusion Criteria

\>18 years of age inclusive Subcutaneous fat in the periumbilical area BMI \<30 kg/msq Stable diet and exercise and body weight

Exclusion Criteria

Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neothetics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Murray C Maytom, MBChB, MBA

Role: STUDY_DIRECTOR

Neothetics, Inc

Locations

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United States, California

Beverly Hills, California, United States

Site Status

United States, California

Encinitas, California, United States

Site Status

United States, California

Los Angeles, California, United States

Site Status

United States, California

San Diego, California, United States

Site Status

United States, California

Santa Ana, California, United States

Site Status

United States, Florida

Aventura, Florida, United States

Site Status

United States, Florida

Clearwater, Florida, United States

Site Status

United States, Florida

Lake Worth, Florida, United States

Site Status

United States, Florida

Miami, Florida, United States

Site Status

United States, Florida

Tampa, Florida, United States

Site Status

United States, Illinois

Buffalo Grove, Illinois, United States

Site Status

United States, Illinois

Chicago, Illinois, United States

Site Status

United States, New York

New York, New York, United States

Site Status

United States, New York

Smithtown, New York, United States

Site Status

United States, North Carolina

Chapel Hill, North Carolina, United States

Site Status

United States, North Carolina

Raleigh, North Carolina, United States

Site Status

United States, Tennessee

Nashville, Tennessee, United States

Site Status

United States, Texas

Austin, Texas, United States

Site Status

United States, Texas

Dallas, Texas, United States

Site Status

United States, Texas

Fort Worth, Texas, United States

Site Status

United States, Texas

Houston, Texas, United States

Site Status

United States, Texas

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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LIPO-202-CL-16

Identifier Type: -

Identifier Source: org_study_id

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