NCT01712451

Brief Summary

Dose ranging study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

October 16, 2012

Last Update Submit

March 5, 2015

Conditions

Abdominal Contour Defects

Keywords

adiposity

Outcome Measures

Primary Outcomes (2)

  • Safety

    physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events

    8 weeks treatment

  • Change in abdominal circumference

    abdominal circumference

    Baseline to 9 weeks

Secondary Outcomes (4)

  • Change in global clinician scale score

    Baseline to 9 weeks

  • Change in global patient scale score

    Baseline to 9 weeks

  • Change in Photonumeric scale score

    Baseline to 9 weeks

  • Change in Patient Reported Outcome Score

    Baseline to 9 weeks

Study Arms (5)

LIPO-102, Low

EXPERIMENTAL
Drug: salmeterol xinafoate, fluticasone propionate

LIPO-102, Mid

EXPERIMENTAL
Drug: salmeterol xinafoate, fluticasone propionate

LIPO-102, High

EXPERIMENTAL
Drug: salmeterol xinafoate, fluticasone propionate

LIPO-102; Placebo

EXPERIMENTAL
Drug: Placebo

salmeterol xinafoate

EXPERIMENTAL
Drug: salmeterol xinafoate

Interventions

salmeterol xinafoate, fluticasone propionateDRUG

LIPO-102

Also known as: LIPO-102
LIPO-102, HighLIPO-102, LowLIPO-102, Mid
PlaceboDRUG

Placebo

LIPO-102; Placebo
salmeterol xinafoateDRUG

Salmeterol

salmeterol xinafoate

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age inclusive
  • abdominal contour defect
  • BMI \<25 kg/msq
  • Stable diet and exercise and body weight

You may not qualify if:

  • Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)
  • Known hypersensitivity to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Plano, Texas, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Fluticasone-Salmeterol Drug CombinationSalmeterol Xinafoate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Murray Maytom

    Neothetics, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 23, 2012

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(6)