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Dose Ranging Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIPO-202, Low | Experimental | Drug: salmeterol xinafoate |
|
| LIPO-202, Mid | Experimental | Drug: salmeterol xinafoate |
|
| LIPO-202, High | Experimental | Drug: salmeterol xinafoate |
|
| LIPO-202, Placebo | Experimental | Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: salmeterol xinafoate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events | 8 weeks treatment |
| Change in global clinician abdominal perception scale score (baseline and 9 weeks) | 9 weeks | |
| Change in global patient abdominal perception scale score (baseline and 9 weeks) | 9 weeks | |
| Change in abdominal circumference (baseline and 9 weeks) | abdominal circumference | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Photonumeric abdominal perception scale score (baseline and 9 weeks) | 9 weeks | |
| Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks) | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subcutaneous abdominal adipose tissue thickness (baseline and 9 weeks) | 9 weeks |
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
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| Name | Affiliation | Role |
|---|---|---|
| Murray C Maytom, MBChB, MBA | Neothetics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, California | Beverly Hills | California | United States | |||
| United States, California |
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| Drug: Placebo | Drug |
|
|
| 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 | 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 | Buffalo Grove | Illinois | United States |
| United States, Illinois | Chicago | Illinois | United States |
| United States, New York | New York | New York | United States |
| United States, New York | Smithtown | New York | United States |
| United States, North Carolina | Chapel Hill | North Carolina | United States |
| United States, North Carolina | Raleigh | North Carolina | United States |
| United States, Tennessee | Nashville | Tennessee | United States |
| 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 |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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