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AUGMENTIN™ in Dental Infections

NCT02141217 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2017-09-25

Study results available
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Summary

In clinical practice, amoxicillin + clavulanic acid is widely used in the treatment of odontogenic infection. Therefore, this study is designed to generate data to support its use by demonstrating efficacy, safety and tolerability in comparison with clindamycin in subjects with acute odontogenic infections with or without abscess. This will be a two-arm, parallel, comparative, observer blind, randomised study to assess efficacy, safety and tolerability of amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin (150mg) administered for 5-7 days in subjects with acute odontogenic infections with or without abscess. The study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infections. A total of 472 subjects will be randomized in 1:1 ratio, i.e. 236 subjects in each treatment arm. The treatment duration of the study will be at least 5 days or maximum 7 days depending upon the treatment response. Subjects will be assessed on Day 5 and if Investigator feels the need of continuing the treatment at Day 5 then treatment will be continued till Day 7. For subjects who do not show treatment response on Day 5, assessments will be performed on Day 7.

Conditions

  • Focal Infection, Dental

Interventions

DRUG

Amoxicillin/clavulanate

Amoxicillin/clavulanate 1 g bd for at least 5 days or maximum 7 days depending upon the treatment response.

DRUG

Clindamycin

Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon the treatment response.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-21
Primary Completion
2013-12-28
Completion
2013-12-28

Countries

  • Malaysia
  • Philippines
  • Thailand
  • Vietnam

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141217 on ClinicalTrials.gov