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Trial record 63 of 439 for:    Methylphenidate

Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

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ClinicalTrials.gov Identifier: NCT00434213
Recruitment Status : Completed
First Posted : February 13, 2007
Results First Posted : March 6, 2009
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Daytrana
Enrollment 309
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daytrana
Hide Arm/Group Description Methylphenidate Transdermal System (MTS)
Period Title: Overall Study
Started 309
Completed 260
Not Completed 49
Reason Not Completed
Adverse Event             12
Lack of Efficacy             9
Lost to Follow-up             14
Withdrawal by Subject             7
Protocol Violation             3
Unable to comply with study visit window             2
Application site reaction             1
Non-compliant to study schedule             1
Arm/Group Title Daytrana
Hide Arm/Group Description Methylphenidate Transdermal System (MTS)
Overall Number of Baseline Participants 309
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 309 participants
<=18 years
309
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 309 participants
9.1  (1.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 309 participants
Female
91
  29.4%
Male
218
  70.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 309 participants
309
1.Primary Outcome
Title Dermal Reactions
Hide Description Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Time Frame 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Daytrana
Hide Arm/Group Description:
Methylphenidate Transdermal System (MTS)
Overall Number of Participants Analyzed 305
Measure Type: Number
Unit of Measure: Participants
0 (no evidence of irritation) 46
1 (minimal erythema) 97
2 (definite eythema) 151
3 (erythema and papules) 6
4 (definite edema) 3
5 (erythema, edema, and papules) 0
6 (vesicular eruption) 0
7 (strong reaction beyond test site) 0
No dermal evaluation 2
2.Secondary Outcome
Title Contact Sensitization to Methylphenidate
Hide Description Contact sensitization to methylphenidate through skin patch testing.
Time Frame 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Daytrana
Hide Arm/Group Description:
Methylphenidate Transdermal System (MTS)
Overall Number of Participants Analyzed 305
Measure Type: Number
Unit of Measure: Participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daytrana
Hide Arm/Group Description Methylphenidate Transdermal System (MTS)
All-Cause Mortality
Daytrana
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Daytrana
Affected / at Risk (%) # Events
Total   0/305 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daytrana
Affected / at Risk (%) # Events
Total   242/305 (79.34%)    
Gastrointestinal disorders   
Abdominal pain upper *  26/305 (8.52%)  36
Nausea *  22/305 (7.21%)  27
Infections and infestations   
Upper respiratory tract infection *  20/305 (6.56%)  20
Metabolism and nutrition disorders   
Decreased appetite *  95/305 (31.15%)  99
Nervous system disorders   
Headache *  50/305 (16.39%)  64
Psychiatric disorders   
Insomnia *  32/305 (10.49%)  34
Affect lability *  22/305 (7.21%)  26
Irritability *  18/305 (5.90%)  18
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after SPONSOR confirms there shall be no multicenter Study publication, the INSTITUTION and/or such PRINCIPAL INVESTIGATOR may publish the results from the INSTITUTION site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amaury Sanchez, Sr. Manager, Regulatory Affairs
Organization: Noven Pharmaceuticals, Inc.
EMail: asanchez@noven.com
Layout table for additonal information
Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00434213     History of Changes
Other Study ID Numbers: SPD485-411
First Submitted: February 12, 2007
First Posted: February 13, 2007
Results First Submitted: February 4, 2009
Results First Posted: March 6, 2009
Last Update Posted: April 26, 2017