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Study of 0416 Ointment in the Treatment of Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01053247
First received: December 9, 2009
Last updated: September 30, 2014
Last verified: September 2014
Results First Received: September 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: 0416
Drug: Vehicle of 0416 test product
Drug: tacrolimus ointment 0.1%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Test

Test product that contains the active pharmaceutical ingredient

Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks

Reference

Reference product that contains active pharmaceutical ingredient

Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.

Vehicle

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks


Participant Flow:   Overall Study
    Test     Reference     Vehicle  
STARTED     269     260     264  
COMPLETED     249     241     236  
NOT COMPLETED     20     19     28  
Withdrawal by Subject                 9                 4                 15  
Lack of Efficacy                 1                 0                 1  
Protocol Violation                 2                 1                 2  
Lost to Follow-up                 8                 5                 7  
Adverse Event                 0                 9                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Test

Test product that contains the active pharmaceutical ingredient

Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks

Reference

Reference product that contains active pharmaceutical ingredient

Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.

Vehicle

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks

Total Total of all reporting groups

Baseline Measures
    Test     Reference     Vehicle     Total  
Number of Participants  
[units: participants]
  269     260     264     793  
Age, Customized  
[units: years]
Mean ± Standard Deviation
       
Age     43.0  ± 16.29     43.7  ± 16.74     43.3  ± 17.14     43.3  ± 16.70  
Gender  
[units: participants]
       
Female     148     158     161     467  
Male     121     102     103     326  
Region of Enrollment  
[units: participants]
       
United States     258     253     255     766  
Central America     11     7     9     27  



  Outcome Measures

1.  Primary:   Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment   [ Time Frame: 2 weeks ]

2.  Secondary:   The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Angela C. Kaplan
Organization: Fougera Pharmaceuticals Inc
phone: 631-659-2256
e-mail: angela.kaplan@sandoz.com


No publications provided


Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01053247     History of Changes
Other Study ID Numbers: 0416
Study First Received: December 9, 2009
Results First Received: September 30, 2014
Last Updated: September 30, 2014
Health Authority: United States: Institutional Review Board
Ecuador: Public Health Ministry
Panama: Ministry of Health
Dominican Republic: Consejo Nacional de Bioetica en Salud