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

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ClinicalTrials.gov Identifier: NCT01737931
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Topical steroid (Dexamethasone)
Drug: Topical antihistamine (Diphenhydramine)
Enrollment 120
Recruitment Details  
Pre-assignment Details A total of 120 eligible subjects received the IMP treatment at least once, and 3 of them were withdrawn from the trial before topical treatment allocation due to subject request (1 subject) and for lack of efficacy evaluation (2 subjects).
Arm/Group Title Topical Steroid Topical Antihistamine No-treatment
Hide Arm/Group Description Topical medication of steroid (Dexamethasone) to the application sites after the patch removal Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal No treatment to the application sites after the patch removal
Period Title: Overall Study
Started 38 40 39
Completed 38 38 38
Not Completed 0 2 1
Reason Not Completed
Withdrawal by Subject             0             1             1
Physician Decision             0             1             0
Arm/Group Title Topical Steroid Topical Antihistamine No-treatment Total
Hide Arm/Group Description Topical medication of steroid (Dexamethasone) to the application sites after the patch removal Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal No treatment to the application sites after the patch removal Total of all reporting groups
Overall Number of Baseline Participants 38 40 39 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 40 participants 39 participants 117 participants
26.7  (4.2) 26.7  (4.8) 26.1  (3.7) 26.5  (4.3)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 39 participants 117 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
 100.0%
40
 100.0%
39
 100.0%
117
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 39 participants 117 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
38
 100.0%
40
 100.0%
39
 100.0%
117
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 38 participants 40 participants 39 participants 117 participants
38 40 39 117
1.Primary Outcome
Title Skin Irritation Score of the Application Site
Hide Description

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.

Time Frame 24 hours after 2 mg/24 hr patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) subjects with a score of ≥ 0.5 (±) at Day 3
Arm/Group Title Topical Steroid Topical Antihistamine No-treatment
Hide Arm/Group Description:
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
No treatment to the application sites after the patch removal
Overall Number of Participants Analyzed 19 19 20
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
0.237
(0.084 to 0.390)
0.289
(0.136 to 0.422)
0.250
(0.101 to 0.399)
2.Primary Outcome
Title Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)
Time Frame 24 hours after 2 mg/24 hr patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Topical Steroid Topical Antihistamine No-treatment
Hide Arm/Group Description:
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
No treatment to the application sites after the patch removal
Overall Number of Participants Analyzed 37 38 38
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
1.6
(0.5 to 2.7)
0.4
(-0.7 to 1.6)
0.9
(-0.2 to 2.0)
3.Secondary Outcome
Title Skin Irritation Score After Patch Removal
Hide Description 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.
Time Frame Up to 72 hours after patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS subjects with a score of ≥ 0.5 (±) at Day 3
Arm/Group Title Topical Steroid Topical Antihistamine No-treatment
Hide Arm/Group Description:
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
No treatment to the application sites after the patch removal
Overall Number of Participants Analyzed 19 18 20
Measure Type: Number
Unit of Measure: Percentage of participants
- (1 hour after patch removal) 5.3 5.6 10.0
± (1 hour after patch removal) 63.2 55.6 45.0
+ (1 hour after patch removal) 31.6 38.9 45.0
- (24 hours after patch removal) 57.9 52.6 60.0
± (24 hours after patch removal) 36.8 36.8 30.0
+ (24 hours after patch removal) 5.3 10.5 10.0
- (48 hours after patch removal) 89.5 94.7 80.0
± (48 hours after patch removal) 10.5 5.3 20.0
- (72 hours after patch removal) 94.4 94.7 90.0
± (72 hours after patch removal) 5.6 5.3 10.0
4.Secondary Outcome
Title Itching of Application Site Evaluated by VAS After Patch Removal
Hide Description

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).

Time Frame Up to 96 hours after patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Topical Steroid Topical Antihistamine No-treatment
Hide Arm/Group Description:
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
No treatment to the application sites after the patch removal
Overall Number of Participants Analyzed 38 39 39
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3 hours after patch removal -2.8  (6.9) -3.0  (9.0) -2.2  (4.6)
6 hours after patch removal -3.3  (7.9) -3.3  (8.6) -2.3  (5.0)
24 hours after patch removal -3.9  (10.0) -2.6  (7.0) -2.6  (4.7)
48 hours after patch removal -3.9  (10.5) -3.6  (9.0) -2.9  (5.1)
72 hours after patch removal -4.1  (10.0) -3.8  (8.9) -3.0  (5.1)
96 hours after patch removal -4.3  (10.1) -3.8  (8.9) -3.0  (5.1)
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Over-all
Hide Arm/Group Description

In this study, all the subjects were received SPM962 with the same dose and regimen during the acceleration and dose-escalation periods and then they were randomized into one of the three groups after removal of SPM962 to evaluate recovery of skin reaction caused by SPM962 using either steroids, antihistamine or no treatment.

Since AEs mainly occurred in the acceleration and dose-escalation periods when SPM962 were used, AEs are shown in one group.

All-Cause Mortality
Over-all
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Over-all
Affected / at Risk (%) # Events
Total   0/120 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Over-all
Affected / at Risk (%) # Events
Total   41/120 (34.17%)    
General disorders   
Application Site Irritation * 1  3/120 (2.50%)  3
Feeling Hot * 1  3/120 (2.50%)  3
Nervous system disorders   
Headache * 1  6/120 (5.00%)  6
Psychiatric disorders   
Somnolence * 1  6/120 (5.00%)  6
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal Pain * 1  6/120 (5.00%)  6
Rhinorrhoea * 1  4/120 (3.33%)  4
Skin and subcutaneous tissue disorders   
Erythema * 1  29/120 (24.17%)  29
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
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