Dose Ranging Study (RESET)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lithera, Inc
ClinicalTrials.gov Identifier:
NCT01802723
First received: February 26, 2013
Last updated: November 11, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Lithera, Inc:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 weeks treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in global patient abdominal perception scale score (baseline and 9 weeks) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Change in abdominal circumference (baseline and 9 weeks) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    abdominal circumference


Secondary Outcome Measures:
  • Change in Photonumeric abdominal perception scale score (baseline and 9 weeks) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in subcutaneous abdominal adipose tissue thickness (baseline and 9 weeks) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Lithera, Inc
Investigators
Study Director: Murray C Maytom, MBChB, MBA Lithera, Inc
  More Information

No publications provided

Responsible Party: Lithera, Inc
ClinicalTrials.gov Identifier: NCT01802723     History of Changes
Other Study ID Numbers: LIPO-202-CL-16
Study First Received: February 26, 2013
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Salmeterol
Albuterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 20, 2014