Phase 1
N=117
A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01737931 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Skin Irritation Score of the Application Site — 0.237; 0.289; 0.250 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Topical steroid (Dexamethasone) (Drug); Topical antihistamine (Diphenhydramine) (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Irritation Score of the Application Site |
0.237; 0.289; 0.250 | — |
| PRIMARY Itching of Application Site Evaluated by the Visual Analogue Scale (VAS) |
1.6; 0.4; 0.9 | — |
| SECONDARY Skin Irritation Score After Patch Removal |
5.3; 5.6; 10.0; 63.2; 55.6; 45.0 | — |
| SECONDARY Itching of Application Site Evaluated by VAS After Patch Removal |
-2.8; -3.0; -2.2; -3.3; -3.3; -2.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01737931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.