Dose-ranging Study

NCT ID: NCT01712451

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

Brief Summary

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Dose ranging study

Detailed Description

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Conditions

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Abdominal Contour Defects

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-102, Low

Group Type EXPERIMENTAL

salmeterol xinafoate, fluticasone propionate

Intervention Type DRUG

LIPO-102

LIPO-102, Mid

Group Type EXPERIMENTAL

salmeterol xinafoate, fluticasone propionate

Intervention Type DRUG

LIPO-102

LIPO-102, High

Group Type EXPERIMENTAL

salmeterol xinafoate, fluticasone propionate

Intervention Type DRUG

LIPO-102

LIPO-102; Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo

salmeterol xinafoate

Group Type EXPERIMENTAL

salmeterol xinafoate

Intervention Type DRUG

Salmeterol

Interventions

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salmeterol xinafoate, fluticasone propionate

LIPO-102

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

salmeterol xinafoate

Salmeterol

Intervention Type DRUG

Other Intervention Names

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LIPO-102

Eligibility Criteria

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Inclusion Criteria

* 18 - 45 years of age inclusive
* abdominal contour defect
* BMI \<25 kg/msq
* Stable diet and exercise and body weight

Exclusion Criteria

* Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)
* Known hypersensitivity to study drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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 Maytom

Role: STUDY_DIRECTOR

Neothetics, Inc

Locations

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Beverly Hills, California, United States

Site Status

San Diego, California, United States

Site Status

New York, New York, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Nashville, Tennessee, United States

Site Status

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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LIPO-102-CL-11

Identifier Type: -

Identifier Source: org_study_id

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