Trial Outcomes & Findings for AUGMENTIN™ in Dental Infections (NCT NCT02141217)
NCT ID: NCT02141217
Last Updated: 2017-09-25
Results Overview
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.
COMPLETED
PHASE4
472 participants
Day 5 or Day 7 [End of treatment]
2017-09-25
Participant Flow
A total of 510 participants (par.) were screened; 472 were randomized to receive one of the two study treatments. Of the 472 par.; 235 par. were randomized to the amoxicillin + clavulanic acid (amx+clv) arm and 237 par. to the clindamycin (clin) arm.
Amongst the randomized par., 236 par. received amx+clv and 235 par. received clin as 2 par. randomized to the clin arm incorrectly received amx+clv and 1 par. randomized to amx+clv arm confirmed not consuming even a single dose of study drug.
Participant milestones
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
Overall Study
STARTED
|
234
|
237
|
|
Overall Study
ITT Population-Randomized Treatment Arm
|
234
|
237
|
|
Overall Study
ITT Population-Actual Treatment Received
|
236
|
235
|
|
Overall Study
COMPLETED
|
223
|
229
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Surgical Intervention
|
1
|
1
|
Baseline Characteristics
AUGMENTIN™ in Dental Infections
Baseline characteristics by cohort
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=234 Participants
Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=237 Participants
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Total
n=471 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
32.6 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
32.9 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian Heritage
|
233 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5 or Day 7 [End of treatment]Population: Per-Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (defined as all randomized participants who received at least one dose of study medication) who were without major protocol violations and had end of treatment clinical response assessment available.
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.
Outcome measures
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=211 Participants
Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=203 Participants
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
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)
|
88.2 Percentage of participants
|
89.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 5 or Day 7 [End of treatment]Population: Intent-To-Treat-Efficacy (ITT-E) Population: all participants in the ITT participants who had at least one post-Baseline assessment of clinical success response (clinical response based on assessment on odontogenic infection and VAS Score).
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.
Outcome measures
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=228 Participants
Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=235 Participants
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
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)
|
85.5 Percentage of participants
|
86.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 5 or Day 7 [End of treatment]Population: Intent-to-Treat (ITT) Population (randomized as per treatment allocation): all randomized participants who received at least one dose of study medication. If the post-Baseline assessment of clinical success response was missing then "Clinical Success" is considered as "No" i.e. the participant was treated as "Clinical Failure".
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.
Outcome measures
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=234 Participants
Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=237 Participants
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
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)
|
83.3 Percentage of participants
|
85.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 5Population: ITT-E Population. Only the participants with Day 5 assessments were considered for analysis.
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.
Outcome measures
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=220 Participants
Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=230 Participants
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5
|
169 Participants
|
159 Participants
|
SECONDARY outcome
Timeframe: Day 5Population: ITT-E Population
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'. .
Outcome measures
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=220 Participants
Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=230 Participants
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
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
|
158 Participants
|
150 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 5 and 7Population: ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.
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).
Outcome measures
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=228 Participants
Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=235 Participants
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7
Day 5, n=219, 228
|
5.49 Scores on a scale
Interval 5.27 to 5.71
|
5.38 Scores on a scale
Interval 5.16 to 5.6
|
|
Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7
Day 7, n=57, 71
|
6.38 Scores on a scale
Interval 6.02 to 6.74
|
6.34 Scores on a scale
Interval 6.02 to 6.66
|
|
Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7
Day 2, n=227, 233
|
3.34 Scores on a scale
Interval 3.08 to 3.61
|
3.07 Scores on a scale
Interval 2.81 to 3.33
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 5 and 7Population: ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.
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).
Outcome measures
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=228 Participants
Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=235 Participants
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7
Day 2, n=219, 225
|
1.92 Scores on a scale
Interval 1.72 to 2.11
|
1.61 Scores on a scale
Interval 1.42 to 1.8
|
|
Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7
Day 5, n=214, 223
|
3.68 Scores on a scale
Interval 3.51 to 3.85
|
3.60 Scores on a scale
Interval 3.43 to 3.76
|
|
Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7
Day 7, n=55, 68
|
4.21 Scores on a scale
Interval 3.94 to 4.49
|
4.61 Scores on a scale
Interval 4.36 to 4.86
|
Adverse Events
Amoxicillin 875 mg + Clavulanic Acid 125 mg
Clindamycin 150 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amoxicillin 875 mg + Clavulanic Acid 125 mg
n=236 participants at risk
Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
Clindamycin 150 mg
n=235 participants at risk
Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.7%
11/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
3.0%
7/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
19/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
11.9%
28/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
11.0%
26/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
10.2%
24/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase decreased
|
3.4%
8/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
0.85%
2/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
10.2%
24/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
8.5%
20/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Investigations
Blood bilirubin increased
|
5.1%
12/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
5.5%
13/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Increased appetite
|
8.5%
20/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
6.4%
15/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Nervous system disorders
Dizziness
|
7.6%
18/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
6.0%
14/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
3.4%
8/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
6.0%
14/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Nervous system disorders
Somnolence
|
8.1%
19/236 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
7.2%
17/235 • 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).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER