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Trial record 54 of 232 for:    clindamycin

AUGMENTIN™ in Dental Infections (AUGDENT)

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ClinicalTrials.gov Identifier: NCT02141217
Recruitment Status : Completed
First Posted : May 19, 2014
Results First Posted : August 28, 2014
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Focal Infection, Dental
Interventions Drug: Amoxicillin/clavulanate
Drug: Clindamycin
Enrollment 472
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 234 237
ITT Population-Randomized Treatment Arm 234 237
ITT Population-Actual Treatment Received 236 235
Completed 223 229
Not Completed 11 8
Reason Not Completed
Adverse Event             1             2
Protocol Violation             1             4
Withdrawal by Subject             6             0
Lost to Follow-up             1             1
Physician Decision             1             0
Surgical Intervention             1             1
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 234 237 471
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants 237 participants 471 participants
33.1  (12.8) 32.6  (12.0) 32.9  (12.4)
[1]
Measure Description: 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.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 237 participants 471 participants
Female
135
  57.7%
143
  60.3%
278
  59.0%
Male
99
  42.3%
94
  39.7%
193
  41.0%
[1]
Measure Description: 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.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 234 participants 237 participants 471 participants
Asian-Central/South Asian Heritage 0 1 1
Asian-East Asian Heritage 1 4 5
Asian-South East Asian Heritage 233 232 465
[1]
Measure Description: 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.
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Day 5 or Day 7 [End of treatment]
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 211 203
Measure Type: Number
Unit of Measure: Percentage of participants
88.2 89.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amoxicillin 875 mg + Clavulanic Acid 125 mg, Clindamycin 150 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.
Method of Estimation Estimation Parameter Treatment Difference (percentage)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-4.9 to 8.0
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Day 5 or Day 7 [End of treatment]
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 228 235
Measure Type: Number
Unit of Measure: Percentage of participants
85.5 86.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amoxicillin 875 mg + Clavulanic Acid 125 mg, Clindamycin 150 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.
Method of Estimation Estimation Parameter Treatment Difference (percentage)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-5.6 to 7.4
Estimation Comments [Not Specified]
3.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Day 5 or Day 7 [End of treatment]
Hide Outcome Measure Data
Hide Analysis Population Description
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”.
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description:
Participants randomized to amoxicillin 875 mg plus clavulanic acid 125 mg.
Participants randomized to clindamycin 150 mg.
Overall Number of Participants Analyzed 234 237
Measure Type: Number
Unit of Measure: Percentage of participants
83.3 85.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amoxicillin 875 mg + Clavulanic Acid 125 mg, Clindamycin 150 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.
Method of Estimation Estimation Parameter Treatment Difference (percentage)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-4.4 to 9.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5
Hide Description 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.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only the participants with Day 5 assessments were considered for analysis.
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 220 230
Measure Type: Number
Unit of Measure: Participants
169 159
5.Secondary Outcome
Title 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
Hide Description 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'. .
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 220 230
Measure Type: Number
Unit of Measure: Participants
158 150
6.Secondary Outcome
Title Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7
Hide Description 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).
Time Frame Baseline, Days 2, 5 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 228 235
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Day 2, n=227, 233
3.34
(3.08 to 3.61)
3.07
(2.81 to 3.33)
Day 5, n=219, 228
5.49
(5.27 to 5.71)
5.38
(5.16 to 5.60)
Day 7, n=57, 71
6.38
(6.02 to 6.74)
6.34
(6.02 to 6.66)
7.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7
Hide Description 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).
Time Frame Baseline, Days 2, 5 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 228 235
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Day 2, n=219, 225
1.92
(1.72 to 2.11)
1.61
(1.42 to 1.80)
Day 5, n=214, 223
3.68
(3.51 to 3.85)
3.60
(3.43 to 3.76)
Day 7, n=55, 68
4.21
(3.94 to 4.49)
4.61
(4.36 to 4.86)
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).
Adverse Event Reporting Description 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.
 
Arm/Group Title Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/236 (0.00%)   0/235 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Amoxicillin 875 mg + Clavulanic Acid 125 mg Clindamycin 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   99/236 (41.95%)   93/235 (39.57%) 
Gastrointestinal disorders     
Abdominal discomfort  1  11/236 (4.66%)  7/235 (2.98%) 
Diarrhoea  1  19/236 (8.05%)  28/235 (11.91%) 
Investigations     
Alanine aminotransferase increased  1  26/236 (11.02%)  24/235 (10.21%) 
Aspartate aminotransferase decreased  1  8/236 (3.39%)  2/235 (0.85%) 
Aspartate aminotransferase increased  1  24/236 (10.17%)  20/235 (8.51%) 
Blood bilirubin increased  1  12/236 (5.08%)  13/235 (5.53%) 
Metabolism and nutrition disorders     
Increased appetite  1  20/236 (8.47%)  15/235 (6.38%) 
Nervous system disorders     
Dizziness  1  18/236 (7.63%)  14/235 (5.96%) 
Headache  1  8/236 (3.39%)  14/235 (5.96%) 
Somnolence  1  19/236 (8.05%)  17/235 (7.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02141217     History of Changes
Other Study ID Numbers: 117044
First Submitted: May 15, 2014
First Posted: May 19, 2014
Results First Submitted: August 14, 2014
Results First Posted: August 28, 2014
Last Update Posted: September 25, 2017