Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment

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.
ClinicalTrials.gov Identifier: NCT01529242
Recruitment Status : Terminated (By sponsor decision due to difficulty of recruitment)
First Posted : February 8, 2012
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
EMS

Tracking Information
First Submitted Date  ICMJE February 6, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date February 16, 2017
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Efficacy of treatment in acute cutaneous rash based on symptoms score [ Time Frame: 5 days ]
The differences in the intensity of signs and symptoms of acute cutaneous rash between the beginning and end of the study will be used as the primary endpoint of clinical efficacy .
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01529242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
Safety will be evaluated by the adverse event occurrences [ Time Frame: 5 days ]
Adverse events will be recorded and followed in order to evaluate safety and tolerability
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Safety will be evaluated by the adverse event occurrences [ Time Frame: 5 days ]
Adverse events will be collected and followed in order to evaluate safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment
Official Title  ICMJE A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash
Brief Summary The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of acute cutaneous rash in children between 2 and 12 years old.
Detailed Description
  • double-blind, non-inferiority, prospective, parallel group trial.
  • Experiment duration: 05 days.
  • 03 visits (day 0, 48 hours and day 5).
  • Efficacy will be evaluated for acute cutaneous rash based on symptoms score
  • Adverse events evaluation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Hypersensitivity
Intervention  ICMJE
  • Drug: Desloratadine + Prednisolone
    Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
  • Drug: Dexchlorpheniramine + Betamethasone
    Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Study Arms  ICMJE
  • Experimental: Desloratadine + Prednisolone
    desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution
    Intervention: Drug: Desloratadine + Prednisolone
  • Active Comparator: Dexchlorpheniramine + Betamethasone
    dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution
    Intervention: Drug: Dexchlorpheniramine + Betamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 15, 2017)
17
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
140
Actual Study Completion Date  ICMJE October 20, 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consent of the patient or legal guardian;
  • Clinical diagnosis of acute cutaneous rash defined by the presence of erythematous papules on healthy skin, different sizes, itchy and fleeting
  • Children aged between 2 and 11 years and 11 months (up to 30 kg);

Exclusion Criteria:

  • Participation in clinical trial in 30 days prior to study entry;
  • Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
  • Patients with any clinically significant disease other than cutaneous rash including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
  • Patients on treatment with monoamine oxidase inhibitors (MAOIs);
  • Patients diagnosed with other dermatoses
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529242
Other Study ID Numbers  ICMJE DPUEMS1111
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMS
Study Sponsor  ICMJE EMS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dirceu Solé, MD Federal University of São Paulo
PRS Account EMS
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP