NCT01553006

Brief Summary

Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about the efficacy of this drug at low and high doses.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

February 17, 2012

Last Update Submit

March 13, 2012

Conditions

Rhinosinusitis

Keywords

rhinosinusitiscefditoren pivoxil

Outcome Measures

Primary Outcomes (1)

  • sinus symptoms scores

    Change of sinus sympotms scores from baseline in 2 weeks

    14 days

Secondary Outcomes (1)

  • relapse rate

    at day 28

Study Arms (2)

cefditoren pivoxil

ACTIVE COMPARATOR

cefditoren 10 mg/kg/day for 14 days

Drug: cefditoren pivoxil

cefditoren pivoxil high dose

ACTIVE COMPARATOR

cefditoren 20 MKD were used to compare efficacy of treatment.

Drug: cefditoren pivoxil

Interventions

cefditoren pivoxilDRUG

comparison of different dosages of cefditoren pivoxil

Also known as: Meiact
cefditoren pivoxilcefditoren pivoxil high dose

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children age 1-15 years old diagnosed acute rhinosinusitis

You may not qualify if:

  • poor compliance
  • other infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University

Prathumthani, 12120, Thailand

RECRUITING

MeSH Terms

Conditions

Rhinosinusitis

Interventions

cefditoren pivoxil

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Orapan Poachanukoon, MD.

    Thammasat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2012

First Posted

March 13, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

TH(1)