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Dose Ranging Study (RESET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802723
First Posted: March 1, 2013
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neothetics, Inc
  Purpose
Dose Ranging Study

Condition Intervention Phase
Periumbilical Subcutaneous Adipose Tissue Reduction Drug: Drug: salmeterol xinafoate Drug: Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area

Resource links provided by NLM:


Further study details as provided by Neothetics, Inc:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 weeks treatment ]
    physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events

  • Change in global clinician abdominal perception scale score (baseline and 9 weeks) [ Time Frame: 9 weeks ]
  • Change in global patient abdominal perception scale score (baseline and 9 weeks) [ Time Frame: 9 weeks ]
  • Change in abdominal circumference (baseline and 9 weeks) [ Time Frame: 9 weeks ]
    abdominal circumference


Secondary Outcome Measures:
  • Change in Photonumeric abdominal perception scale score (baseline and 9 weeks) [ Time Frame: 9 weeks ]
  • Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks) [ Time Frame: 9 weeks ]

Other Outcome Measures:
  • Change in subcutaneous abdominal adipose tissue thickness (baseline and 9 weeks) [ Time Frame: 9 weeks ]

Enrollment: 472
Study Start Date: February 2013
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-202, Low
Drug: salmeterol xinafoate
Drug: Drug: salmeterol xinafoate
Other Names:
  • LIPO-202
  • Salmeterol
Experimental: LIPO-202, Mid
Drug: salmeterol xinafoate
Drug: Drug: salmeterol xinafoate
Other Names:
  • LIPO-202
  • Salmeterol
Experimental: LIPO-202, High
Drug: salmeterol xinafoate
Drug: Drug: salmeterol xinafoate
Other Names:
  • LIPO-202
  • Salmeterol
Experimental: LIPO-202, Placebo
Drug: Placebo
Drug: Drug: Placebo
Other Name: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802723


Locations
United States, California
United States, California
Beverly Hills, California, United States
United States, California
Encinitas, California, United States
United States, California
Los Angeles, California, United States
United States, California
San Diego, California, United States
United States, California
Santa Ana, California, United States
United States, Florida
United States, Florida
Aventura, Florida, United States
United States, Florida
Clearwater, Florida, United States
United States, Florida
Lake Worth, Florida, United States
United States, Florida
Miami, Florida, United States
United States, Florida
Tampa, Florida, United States
United States, Illinois
United States, Illinois
Buffalo Grove, Illinois, United States
United States, Illinois
Chicago, Illinois, United States
United States, New York
United States, New York
New York, New York, United States
United States, New York
Smithtown, New York, United States
United States, North Carolina
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Tennessee
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
United States, Texas
Austin, Texas, United States
United States, Texas
Dallas, Texas, United States
United States, Texas
Fort Worth, Texas, United States
United States, Texas
Houston, Texas, United States
United States, Texas
Plano, Texas, United States
Sponsors and Collaborators
Neothetics, Inc
Investigators
Study Director: Murray C Maytom, MBChB, MBA Neothetics, Inc
  More Information

Responsible Party: Neothetics, Inc
ClinicalTrials.gov Identifier: NCT01802723     History of Changes
Other Study ID Numbers: LIPO-202-CL-16
First Submitted: February 26, 2013
First Posted: March 1, 2013
Last Update Posted: March 26, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action