Evaluation of Adhesion and Dermal Tolerability of EMSAM
NCT ID: NCT00531596
Last Updated: 2007-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2007-04-30
2007-07-31
Brief Summary
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Detailed Description
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The secondary objective is to examine if the adhesion characteristics and dermal tolerability (irritation) of EMSAM may be influenced by the secondary factors such as gender, race, physical activity, and bathing/showering practices.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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A
EMSAM 6mg/24hr
EMSAM (Selegiline Transdermal System) 6mg/24Hr
EMSAM 6mg/24HR
B
EMSAM 9mg/24Hr
EMSAM (Selegiline Transdermal System) 9mg/24Hr
EMSAM 9mg/24Hr
C
EMSAM 12mg/24Hr
EMSAM (Selegiline Transdermal System) 12mg/24hr
EMSAM 12mg/24Hr
Interventions
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EMSAM (Selegiline Transdermal System) 6mg/24Hr
EMSAM 6mg/24HR
EMSAM (Selegiline Transdermal System) 9mg/24Hr
EMSAM 9mg/24Hr
EMSAM (Selegiline Transdermal System) 12mg/24hr
EMSAM 12mg/24Hr
Eligibility Criteria
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Inclusion Criteria
* Able and willing to provide written informed consent.
* Able and willing to follow a modified diet.
* 18 years of age and older.
* Male or female.
* If female and of childbearing potential, subject must have a negative pregnancy screen at baseline and may not be lactating. Females of childbearing potential must demonstrate use of an acceptable form of birth control, such as hormonal contraceptive, intrauterine device or barrier method (i.e. condom w/spermicide). NOTE: Abstinence and partner vasectomy are not acceptable methods of contraception.
* In general good health as ascertained by physical examination, supine and standing vital signs, laboratory test results, 12 lead ECG and medical history.
Exclusion Criteria
* Subjects with a past or present condition that includes any of the following:
1. In the opinion of the Investigator, any significant cardiovascular disease or disorder including myocardial infarction, cardiac arrhythmia, hypertension or recurrent episodes of orthostatic hypotension.
2. Any skin abnormalities at or near designated patch application sites that might interfere with the conduct or interpretation of the study including the presence of moles, blemishes, excess hair, scars, tattoos, sunburn or other marks on the application sites that may obscure grading of the site(s).
3. Any known hypersensitivity, or related hypersensitivity, to selegiline or to skin adhesives (i.e. surgical tape, etc.).
4. Any significant immunological, pulmonary, hematologic, endocrine and/or metabolic disease or disorder or severe or acute medical illness, such as, metastatic cancer, brain tumors, decompensated cardiac, hepatic or renal failure.
5. Neurological disorders including delirium, history of significant head trauma, movement disorders, dementia, multiple sclerosis or stroke.
6. Any psychiatric disorders (except personality disorders) requiring treatment or therapy within the last three months.
7. Any mood disorder including MDD which is current or relapsed over the past three years.
8. Attention deficit hyperactivity disorder or attention deficit disorder.
9. Any other condition, illness or disorder that in the opinion of the Investigator would place the subject at significant risk or any inability to follow the requirements of the study regarding maintaining scheduled visits or patch applications.
10. Known substance abuse or addiction.
11. Any significant allergy, especially involving dermal manifestations.
12. History of sun hypersensitivity and photosensitive dermatoses.
* Recent or current treatment with systemic or topical drugs or medications which can interfere with skin responses (i.e. steroids, corticosteroids, antihistamines or anti-inflammatory agents). Daily regimens of low-dose aspirin is acceptable.
* Current or anticipated use of meperidine, tricyclic antidepressants, or selective serotonin reuptake inhibitors (i.e., fluoxetine \[Prozacī\], etc) and other antidepressant medications (e.g., SNRI's, MAOI's, buproprion, etc).
* Use of any herbal or homeopathic remedies (excluding vitamins, fish oil, echinacea, glucosamine, chondroitin or calcium)within 14 days of study drug administration, during study conduct and 14 days after the completion of the study medication.
* Participation in a clinical investigation within 28 days prior to baseline.
* Current use of any agents listed as contraindicated (Section 10.3.1.3) or as listed in the approved label
18 Years
ALL
Yes
Sponsors
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Somerset Pharmaceuticals
INDUSTRY
Principal Investigators
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Melissa Goodhead
Role: STUDY_CHAIR
Somerset Pharmaceuticals
Locations
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Hill Top Research
Scottsdale, Arizona, United States
Hill Top Research
St. Petersburg, Florida, United States
Countries
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Other Identifiers
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S9303-P0602
Identifier Type: -
Identifier Source: org_study_id