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Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis (RS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Orapan Poachanukoon, Thammasat University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01553006
First Posted: March 13, 2012
Last Update Posted: March 14, 2012
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):
Orapan Poachanukoon, Thammasat University
February 17, 2012
March 13, 2012
March 14, 2012
January 2012
August 2012   (Final data collection date for primary outcome measure)
sinus symptoms scores [ Time Frame: 14 days ]
Change of sinus sympotms scores from baseline in 2 weeks
Primary outcome (response rate) [ Time Frame: 14 days ]
Change of sinus sympotms score at 2 weeks
Complete list of historical versions of study NCT01553006 on ClinicalTrials.gov Archive Site
relapse rate [ Time Frame: at day 28 ]
The relapse rate of sinus symptoms scores at day 28.
Secondary outcome (relapse rate) [ Time Frame: at day 28 ]
The relapse rate was recorded at day 28.
Not Provided
Not Provided
 
Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis
A Comparison of Cefditoren Pivoxil 10 mg/kg/Day and Cefditoren Pivoxil 20 mg/kg/Day in Treatment of Childhood With Acute Rhinosinusitis
Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about the efficacy of this drug at low and high doses.
The investigation was a randomized, investigator-blinded, and parallel study, conducted in patients (age 1-15 years) with acute rhinosinusitis. Two groups of patients were randomized received low (10 MKD) or high (20 MKD) of drug for 14 days. Changes in sinus symptoms scores, response rate and adverse effect were evaluated at days 7 and 14. Relapse rate was recorded at days 21 and 28. Recurrence of sinus symptoms at day 60 were assessed.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Rhinosinusitis
Drug: cefditoren pivoxil
comparison of different dosages of cefditoren pivoxil
Other Name: Meiact
  • Active Comparator: cefditoren pivoxil
    cefditoren 10 mg/kg/day for 14 days
    Intervention: Drug: cefditoren pivoxil
  • Active Comparator: cefditoren pivoxil high dose
    cefditoren 20 MKD were used to compare efficacy of treatment.
    Intervention: Drug: cefditoren pivoxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
September 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

  • poor compliance
  • other infections
Sexes Eligible for Study: All
1 Year to 15 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01553006
MTU-EC-PE-5-036/54
Yes
Not Provided
Not Provided
Orapan Poachanukoon, Thammasat University
Thammasat University
Not Provided
Principal Investigator: Orapan Poachanukoon, MD. Thammasat University
Thammasat University
March 2012

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