NCT02141217: AUGDENT

AUGMENTIN™ in Dental Infections

Completed Phase 4 Results posted Last updated 25 September 2017

What this trial tests

Phase 4 trial testing Amoxicillin/clavulanate in Focal Infection, Dental in 472 participants. Completed in 28 December 2013.

Timeline

21 March 2013

Primary endpoint
28 December 2013

28 December 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	472
Start date	21 March 2013
Primary completion	28 December 2013
Estimated completion	28 December 2013
Sites	15 locations across Philippines, Thailand, Vietnam, Malaysia

Drugs / interventions tested

• Amoxicillin/clavulanate
• Clindamycin (clindamycin) — full drug profile →

Conditions studied

• Focal Infection, Dental — all drugs for Focal Infection, Dental →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 75, any sex, with Focal Infection, Dental. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · Day 5 or Day 7 [End of treatment]

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 experienc

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	88.2
Clindamycin 150 mg	89.7

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) Primary · Day 5 or Day 7 [End of treatment]

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 experienc

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	85.5
Clindamycin 150 mg	86.4

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) Primary · Day 5 or Day 7 [End of treatment]

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 experienc

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	83.3
Clindamycin 150 mg	85.7

Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5 Secondary · 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 experienc

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	169
Clindamycin 150 mg	159

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 Secondary · 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 ther

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	158
Clindamycin 150 mg	150

Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7 Secondary · 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).

Day 2, n=227, 233

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	3.34	3.08 – 3.61
Clindamycin 150 mg	3.07	2.81 – 3.33

Day 5, n=219, 228

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	5.49	5.27 – 5.71
Clindamycin 150 mg	5.38	5.16 – 5.60

Day 7, n=57, 71

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	6.38	6.02 – 6.74
Clindamycin 150 mg	6.34	6.02 – 6.66

Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7 Secondary · 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).

Day 2, n=219, 225

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	1.92	1.72 – 2.11
Clindamycin 150 mg	1.61	1.42 – 1.80

Day 5, n=214, 223

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	3.68	3.51 – 3.85
Clindamycin 150 mg	3.60	3.43 – 3.76

Day 7, n=55, 68

Group	Value	95% CI
Amoxicillin 875 mg + Clavulanic Acid 125 mg	4.21	3.94 – 4.49
Clindamycin 150 mg	4.61	4.36 – 4.86

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the Baseline (Day 0) until the last dose of study drug (Day 7) or early withdrawal (average of Day 5.88).. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Amoxicillin 875 mg + Clavulanic Acid 125 mg

Serious: 0/236 (0%)

Deaths: —

Clindamycin 150 mg

Serious: 0/235 (0%)

Deaths: —

Other adverse events (10 terms — click to expand)

Reaction	System	Amoxicillin 875 mg + Clavu…	Clindamycin 150 mg
Diarrhoea	Gastrointestinal disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Increased appetite	Metabolism and nutrition disorders	—	—
Somnolence	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Blood bilirubin increased	Investigations	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Aspartate aminotransferase decreased	Investigations	—	—

Data from ClinicalTrials.gov NCT02141217 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin.
   Tancawan AL, Pato MN, Abidin KZ, Asari AS, et al · · 2015 · cited 17× · PMID 26300919 · DOI 10.1155/2015/472470