Clinical Trial: AUGMENTIN™ in Dental Infections

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy, Safety and Tolerability of Amoxicillin + Clavulanic Acid (875mg/125mg) Two Times a Day Compared to Clindamycin (150mg) Four Times a Day for 5-7 Days in Treatment of Acute Odontogenic Infecti

Brief 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.

Detailed Summary:

This two-arm, parallel, comparative, observer blind, randomised study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infection with or without abscess. A total of 472 subjects will be randomised in 1:1 ratio to get 205 evaluable subjects in each study arm. After obtaining informed consent, subject will undergo surgical intervention including surgical incisions, drainages, removal of the involved tooth, debridement, puncture lavage or trephination, if deemed necessary by the Investigator. These surgical interventions will be performed before the start of study treatment. On Day 0 after confirming the eligibility, subjects will be randomised to either of the study arms. The treatment duration of the study will be at least 5 days which may increase to 7 days, if Investigator feels the need of continuing the treatment at Day 5. In such cases clinical assessment will be done again at Day 7. Thus the efficacy evaluation will be performed at baseline (Day 0) prior to study drug administration and on Day 5 and/ or 7. Safety laboratory evaluations will be performed at Screening Visit and will be repeated at end of study treatment i.e. either on Day 5 or Day 7. On Baseline, Day 2, Day 5 and/ or Day 7, Visual Analogue Scale (VAS) will be used to measure amount of pain and swelling that a subject will experience. This scale has numerical ratings from 0 to 10. Zero would mean "No pain" and 10 would mean "Worst possible pain". The subject will be asked to choose the most appropriate score on VAS which best describes his/her pain status over last 24 hours. While using VAS for swelling, zero would mean "No swelling" and 10 would mean "Maximum possible swelling". The Investigator will choose the most appropriate score on VAS which best describes subject's swelling.

Sample for microb
Sponsor: GlaxoSmithKline

Current Primary Outcome: Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7) [ Time Frame: Day 5 or Day 7 [End of treatment] ]

Original Primary Outcome: Clinical Success at End of Treatment [ Time Frame: EOT (day 5/7) ]

Current Secondary Outcome:

• Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5 [ Time Frame: Day 5 ]
  Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.
• Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5 [ Time Frame: Day 5 ]
  CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but 'no change' or 'worsening from BL' in other s/sx (like increased leucocyte count/tooth mobility), the inv's opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with 'no change' or 'worsening from BL' in these other s/sx were considered as cl failures and termed 'Without Considering Cl Jdg of Inv', even though main s/sx are 'cured' or 'improved'. .
• Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7 [ Time Frame: Baseline, Days 2, 5 and 7 ]
  Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).
• Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7 [ Time Frame: Baseline, Days 2, 5 and 7 ]
  Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).

Original Secondary Outcome:

• Clinical success at Day 5 [ Time Frame: 5 days ]
  • Percentage of subjects achieving clinical success at Day 5
• Change in Visual analogue Scale for Pain [ Time Frame: Day 2,5 and 7 ]
  • Change in score on Visual Analogue Scale for assessment of pain from baseline to Day 2, 5 and 7
• Visual analogue Scale for Swelling [ Time Frame: Day 2, 5 and 7 ]
  • Change in score on Visual Analogue Scale for assessment of swelling from baseline to Day 2, 5 and 7
• Adverse Events [ Time Frame: Day 7 ]
  Percentage of subjects having adverse events

Dates:
Date Received: May 15, 2014
Date Started: March 2013
Date Completion:
Last Updated: September 11, 2014
Last Verified: August 2014