Clinical trial NCT01737931: A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
Official title: An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: SPM 962
rotigotine
application site reaction
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines for application site reaction (ASR) after administration of SPM 962 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Subject is a male or female and aged between 20 and 45 years of age (inclusive)
* Subject is of normal body weight as determined by a body-mass index (BMI) between 18 and 28 kg/m2
* Subject is healthy as determined by EA (medical history, physical examination, skin evaluation, vital signs, ECG, hematology, clinical chemistry, urinalysis)
* Subject is surgically sterile; subject has been postmenopausal for at least 12 consecutive months if female; or subject agrees to remain abstinent or to follow two acceptable methods of birth control from EA to the end of observation period. (fore male and female subjects)

Exclusion Criteria:

* Subject has a history or complication of epilepsy and/or seizures
* Subject has clinically relevant changes in the ECG, such as second- or third-degree AV block, a complete bundle branch block, prolongation of the QRS complex over 120 ms, or of the QTcB (QT interval corrected for HR by Bazett´s formula) over 500 ms at EA
* Subject has a clinically relevant hepatic dysfunction
* Subject has a clinically relevant renal dysfunction
* Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis
* Subject has a history or complication of atopic or eczematous dermatitis, psoriasis, and/or an active skin disease or skin tumors
* Subject has more than 1 known or suspected drug hypersensitivity, in particular to any component of the trial medication
* Subject has a history of chronic alcohol or drug abuse within the last 5 years
* Subject is tested positive for HIV-1/2Ab, HBsAg or HCV-Ab
* Subject tests positive for alcohol and/or drugs at EA
* Subject is taking any prohibited concomitant medication
* Subject has a history or complication of narrow angle glaucoma
* Subject has a history or complication of respiratory or cardiovascular disorders (e.g., heart failure, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction)
* Subject has a history or complication of psychic abnormality, psychiatric or neurologic illness, or autonomic neuropathy
* Subject has a history or complication of diabetes mellitus and/or thyroid dysfunction, especially hyperthyroidism or other endocrine disorders
* Subject has a history or complication of malignancy

Primary outcomes:
measure: Skin Irritation Score of the Application Site
timeFrame: 24 hours after 2 mg/24 hr patch removal
measure: Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)
timeFrame: 24 hours after 2 mg/24 hr patch removal
Secondary outcomes:
measure: Skin Irritation Score After Patch Removal
timeFrame: Up to 72 hours after patch removal
measure: Itching of Application Site Evaluated by VAS After Patch Removal
timeFrame: Up to 96 hours after patch removal
Other outcomes:
Locations:
city: Kyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kyoji Imaoka, Mr
role: STUDY_DIRECTOR
References: