Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

NCT ID: NCT01553006

Last Updated: 2012-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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cefditoren pivoxil

cefditoren 10 mg/kg/day for 14 days

Group Type ACTIVE_COMPARATOR

cefditoren pivoxil

Intervention Type DRUG

comparison of different dosages of cefditoren pivoxil

cefditoren pivoxil high dose

cefditoren 20 MKD were used to compare efficacy of treatment.

Group Type ACTIVE_COMPARATOR

cefditoren pivoxil

Intervention Type DRUG

comparison of different dosages of cefditoren pivoxil

Interventions

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cefditoren pivoxil

comparison of different dosages of cefditoren pivoxil

Intervention Type DRUG

Other Intervention Names

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Meiact

Eligibility Criteria

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Inclusion Criteria

* children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria

* poor compliance
* other infections
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Orapan Poachanukoon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orapan Poachanukoon, MD.

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Locations

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Thammasat University

Prathumthani, , Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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Orapan Poachanukoon, MD.

Role: primary

66819316781

Other Identifiers

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MTU-EC-PE-5-036/54

Identifier Type: -

Identifier Source: org_study_id

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