Dose-ranging Study

Overview

Dose ranging study

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2012

Interventions

  • Drug: salmeterol xinafoate, fluticasone propionate
    • LIPO-102
  • Drug: Placebo
    • Placebo
  • Drug: salmeterol xinafoate
    • Salmeterol

Arms, Groups and Cohorts

  • Experimental: LIPO-102, Low
  • Experimental: LIPO-102, Mid
  • Experimental: LIPO-102, High
  • Experimental: LIPO-102; Placebo
  • Experimental: salmeterol xinafoate

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Neothetics, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Murray Maytom, Study Director, Neothetics, Inc

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