Dose-ranging Study (LIPO-102-CL-11)

March 5, 2015 updated by: Neothetics, Inc

Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects

Dose ranging study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States
      • San Diego, California, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Plano, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIPO-102, Low
Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Names:
  • LIPO-102
Experimental: LIPO-102, Mid
Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Names:
  • LIPO-102
Experimental: LIPO-102, High
Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Names:
  • LIPO-102
Experimental: LIPO-102; Placebo
Drug: Placebo
Placebo
Experimental: salmeterol xinafoate
Drug: salmeterol xinafoate
Salmeterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 8 weeks treatment
physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
8 weeks treatment
Change in abdominal circumference
Time Frame: Baseline to 9 weeks
abdominal circumference
Baseline to 9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in global clinician scale score
Time Frame: Baseline to 9 weeks
Baseline to 9 weeks
Change in global patient scale score
Time Frame: Baseline to 9 weeks
Baseline to 9 weeks
Change in Photonumeric scale score
Time Frame: Baseline to 9 weeks
Baseline to 9 weeks
Change in Patient Reported Outcome Score
Time Frame: Baseline to 9 weeks
Baseline to 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neothetics, Inc

Investigators

  • Study Director: Murray Maytom, Neothetics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 16, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (Estimate)

October 23, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPO-102-CL-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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