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A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737931
First Posted: November 30, 2012
Last Update Posted: April 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
  Purpose
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

Condition Intervention Phase
Healthy Drug: Topical steroid (Dexamethasone) Drug: Topical antihistamine (Diphenhydramine) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Skin Irritation Score of the Application Site [ Time Frame: 24 hours after 2 mg/24 hr patch removal ]

    Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.

    The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.


  • Itching of Application Site Evaluated by the Visual Analogue Scale (VAS) [ Time Frame: 24 hours after 2 mg/24 hr patch removal ]

    Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.

    The score ranges from 0 (no itching) to 100 (strongest imaginable itching).



Secondary Outcome Measures:
  • Skin Irritation Score After Patch Removal [ Time Frame: Up to 72 hours after patch removal ]
    Numbers of subjects with each skin irritation score. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.

  • Itching of Application Site Evaluated by VAS After Patch Removal [ Time Frame: Up to 96 hours after patch removal ]

    Changes of itching of application site evaluated by VAS after patch removal (acceleration and dose-escalation periods).

    The score ranges from 0 (no itching) to 100 (strongest imaginable itching).



Enrollment: 120
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical Steroid
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
Drug: Topical steroid (Dexamethasone)
for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for steroid: twice daily administration of Dexamethasone (1 mg/g cream) to the application sites after the patch removal
Experimental: Topical antihistamine
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
Drug: Topical antihistamine (Diphenhydramine)
for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for antihistamine: twice daily administration of Diphenhydramine (10 mg/g cream) to the application sites after the patch removal
No Intervention: No-treatment
No treatment to the application sites after the patch removal

  Eligibility

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737931


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Kyeonggi-do, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Kyoji Imaoka, Mr Otsuka Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01737931     History of Changes
Other Study ID Numbers: 243-12-002
First Submitted: November 25, 2012
First Posted: November 30, 2012
Results First Submitted: February 9, 2014
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014
Last Verified: March 2014

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
SPM 962
rotigotine
application site reaction

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Diphenhydramine
BB 1101
Promethazine
Histamine H1 Antagonists
Histamine Antagonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Histamine Agents
Neurotransmitter Agents
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics