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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lithera, Inc
ClinicalTrials.gov Identifier:
NCT01712451
First received: October 16, 2012
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

Dose ranging study


Condition Intervention Phase
Abdominal Contour Defects
 Drug: salmeterol xinafoate, fluticasone propionate
Drug: Placebo
Drug: salmeterol xinafoate
 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: Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects

Resource links provided by NLM:

U.S. FDA Resources

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 abdominal circumference [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
    abdominal circumference


Secondary Outcome Measures:
  • Change in global clinician scale score [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
  • Change in global patient scale score [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
  • Change in Photonumeric scale score [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
  • Change in Patient Reported Outcome Score [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-102, Low Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Name: LIPO-102
Experimental: LIPO-102, Mid Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Name: LIPO-102
Experimental: LIPO-102, High Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Name: LIPO-102
Experimental: LIPO-102; Placebo Drug: Placebo
Placebo
Experimental: salmeterol xinafoate Drug: salmeterol xinafoate
Salmeterol

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712451

Locations
United States, California
Beverly Hills, California, United States
San Diego, California, United States
United States, New York
New York, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Plano, Texas, United States
Sponsors and Collaborators
Lithera, Inc
Investigators
Study Director: Murray Maytom Lithera, Inc
  More Information

No publications provided

Responsible Party: Lithera, Inc
ClinicalTrials.gov Identifier: NCT01712451     History of Changes
Other Study ID Numbers: LIPO-102-CL-11
Study First Received: October 16, 2012
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Lithera, Inc:
adiposity

Additional relevant MeSH terms:
Salmeterol
Albuterol
Fluticasone
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
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013