Trial Outcomes & Findings for Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid (NCT NCT04411914)
NCT ID: NCT04411914
Last Updated: 2023-06-22
Results Overview
Brain glutamate concentration in the ACC (based on Magnetic Resonance Spectroscopy (MRS)) will be correlated with cocaine craving (measured by Cocaine Craving Questionnaire (CCQ)) in subjects receiving escalating doses of CLAV for 10 days. Measurement will be made at baseline and Day 10 of CLAV (1000 mg/day) in subjects with cocaine use disorder.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
ACC glutamate and CCQ will be measured and correlated on Day 10 of treatment with CLAV compared with baseline.
Results posted on
2023-06-22
Participant Flow
Recruitment materials included newspapers, facebook, and word of mouth. Participants were recruited from the local community between 9/2020 and 11/2021.
Participant milestones
| Measure |
Clavulanic Acid
10 Participants will receive CLAV for 10 days over 3 Periods with no CLAV for Day 11.
Period 1 CLAV 500 mg/day for 3 days dose Period 2- CLAV 750 mg/day for 3 days. Period 3 CLAV 1000mg for 4 days
Clavulanic Acid Only Product: Drug will be given in 250mg capsules.
|
Placebo
3 participants will receive placebo and serve as a control group. They will be blinded to their condition and will have a "dose" escalation at the same time as the experimental group, and be given additional placebo pills to match the number given to the experimental group.
Placebo: Placebo
|
|---|---|---|
|
CLAV 500mg/Day for Days 1-3
STARTED
|
10
|
3
|
|
CLAV 500mg/Day for Days 1-3
COMPLETED
|
9
|
3
|
|
CLAV 500mg/Day for Days 1-3
NOT COMPLETED
|
1
|
0
|
|
CLAV 750mg/Day for Days 4-6
STARTED
|
9
|
3
|
|
CLAV 750mg/Day for Days 4-6
COMPLETED
|
9
|
3
|
|
CLAV 750mg/Day for Days 4-6
NOT COMPLETED
|
0
|
0
|
|
CLAV 1000m/d for Days 7-10
STARTED
|
9
|
3
|
|
CLAV 1000m/d for Days 7-10
COMPLETED
|
9
|
3
|
|
CLAV 1000m/d for Days 7-10
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Clavulanic Acid
10 Participants will receive CLAV for 10 days over 3 Periods with no CLAV for Day 11.
Period 1 CLAV 500 mg/day for 3 days dose Period 2- CLAV 750 mg/day for 3 days. Period 3 CLAV 1000mg for 4 days
Clavulanic Acid Only Product: Drug will be given in 250mg capsules.
|
Placebo
3 participants will receive placebo and serve as a control group. They will be blinded to their condition and will have a "dose" escalation at the same time as the experimental group, and be given additional placebo pills to match the number given to the experimental group.
Placebo: Placebo
|
|---|---|---|
|
CLAV 500mg/Day for Days 1-3
Adverse Event
|
1
|
0
|
Baseline Characteristics
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
Baseline characteristics by cohort
| Measure |
Clavulanic Acid
n=10 Participants
10 participants randomized to the CLAV group
Clavulanic Acid will be given in 250mg capsules according to the 3 Periods
|
Placebo
n=3 Participants
3 participants will receive placebo (PBO) and serve as a control group. They will have a "dose" escalation at the same time as the experimental group, and be given additional placebo pills to match the number given to the experimental group.
Placebo: Placebo
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
n=5 Participants
|
57.8 years
n=7 Participants
|
55.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Handedness
left-handed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Handedness
right-handed
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
Left formal education at 16
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
Left formal education at 17-18
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education
Undergraduate or Equivalent
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ACC glutamate and CCQ will be measured and correlated on Day 10 of treatment with CLAV compared with baseline.Population: Glutamate (Glu) level (MR-Spectroscopy) in the ACC (9 scans at baseline and 9 scans at Day 10, adjusted for baseline) are correlated with CCQ results (9 baseline questionnaires and 9 day 10 questionnaires). Spearman Correlation Coefficients were calculated. Higher concentrations of ACC glutamate on day 10 correlated with decreased cocaine craving.
Brain glutamate concentration in the ACC (based on Magnetic Resonance Spectroscopy (MRS)) will be correlated with cocaine craving (measured by Cocaine Craving Questionnaire (CCQ)) in subjects receiving escalating doses of CLAV for 10 days. Measurement will be made at baseline and Day 10 of CLAV (1000 mg/day) in subjects with cocaine use disorder.
Outcome measures
| Measure |
Clavulanic Acid Day 10
n=18 MRS Scans and CCQ
9 participants who completed Periods 1, 2 and 3 were assessed for brain Glutamate levels in the ACC using MRS at the end of Period 3 (Day 10.)This measure was correlated with CCQ on day 10 adjusted for the baseline.
|
Clavulanic Acid Baseline
n=18 MRS Scans and CCQ
Same 9 subjects underwent CCQ and MRS on Day 1 prior to receiving CLAV 500 mg.
|
Female CLAV Subjects--CCQ Score Day 10
CCQ-45 scores from day 10 in female subjects (they took CLAV 500mg/3 for the first 3 days, then 750 mg/day for days for 3 days and 1000mg/day for 4 days) minus the baseline scores.
|
Femaile PBO Subjects--CCQ Scores Day 10
The CCQ scores day 10 minus the baseline scores in female submects who took matched PBO for 10 days.
|
|---|---|---|---|---|
|
Brain Glutamate Concentration in the Anterior Cingulate Cortex (ACC) in Subjects With Cocaine Use Disorder (CUD) Treated With Escalating Doses of Clavulanate (CLAV)
|
-0.9000 Spearman Correlation Coefficient
|
0.3333 Spearman Correlation Coefficient
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessment was done at the end of Period 1, 2 and 3 detailed above. Data from the end of Period 3 (Day 10, 1000mg CLAV) are reported.Population: 9 participants completed Period 1 (3 days of CLAV 500mg) Period 2 (3 days of CLAV 750mg) and then Period 3 (4 days of CLAV 1000mg). The rs-fMRI activity in the executive control network and CCQ were correlated using the Spearman Correlation calculation at the end of this course of study drug (Day 10) and are reported.
Craving-associated neurocircuitry (frontal-striatal-thalamic connectivity) will be examined with resting state functional Magnetic Resonance Imaging (rs-fMRI) and Cocaine Craving Questionnaire (CCQ-45). The CCQ is comprised of five 9-item sub-scales (desire to use cocaine, intention and planning to use cocaine, anticipation of positive outcome from use, anticipation of relief from withdrawal or dysphoria, and lack of control over use) measured on a scale of 1 to 7, total scores ranging from 45 to 315 with higher numbers indicating increased craving.. The rs-fMRI activity and CCQ were assessed in the 9 participants at baseline and at the end of each of 3 periods. rs-fMRI activity and CCQ were correlated using the Spearman Correlation Coefficient calculation. A negative correlation coefficient indicates an inverse relationship between the assessments; higher rs-fMRI activity correlates with lower craving.
Outcome measures
| Measure |
Clavulanic Acid Day 10
n=9 Participants
9 participants who completed Periods 1, 2 and 3 were assessed for brain Glutamate levels in the ACC using MRS at the end of Period 3 (Day 10.)This measure was correlated with CCQ on day 10 adjusted for the baseline.
|
Clavulanic Acid Baseline
Same 9 subjects underwent CCQ and MRS on Day 1 prior to receiving CLAV 500 mg.
|
Female CLAV Subjects--CCQ Score Day 10
CCQ-45 scores from day 10 in female subjects (they took CLAV 500mg/3 for the first 3 days, then 750 mg/day for days for 3 days and 1000mg/day for 4 days) minus the baseline scores.
|
Femaile PBO Subjects--CCQ Scores Day 10
The CCQ scores day 10 minus the baseline scores in female submects who took matched PBO for 10 days.
|
|---|---|---|---|---|
|
Changes in Resting State Network Connectivity From Baseline
|
-0.8333 Spearman Correlation Coefficient
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: CCQ-45 questionnaires were completed daily during the study. Data from day 10 adjusted for baseline score are reported.Craving will be evaluated by Cocaine Craving Questionnaire (CCQ-45). The CCQ is comprised of five 9-item sub-scales (desire to use cocaine, intention and planning to use cocaine, anticipation of positive outcome from use, anticipation of relief from withdrawal or dysphoria, and lack of control over use) measured on a scale of 1 to 7, total scores ranging from 45 to 315 with higher numbers indicating increased craving. The results are the CCQ scores on day 10 minus the baseline scores before starting study drug.
Outcome measures
| Measure |
Clavulanic Acid Day 10
n=6 Participants
9 participants who completed Periods 1, 2 and 3 were assessed for brain Glutamate levels in the ACC using MRS at the end of Period 3 (Day 10.)This measure was correlated with CCQ on day 10 adjusted for the baseline.
|
Clavulanic Acid Baseline
n=2 Participants
Same 9 subjects underwent CCQ and MRS on Day 1 prior to receiving CLAV 500 mg.
|
Female CLAV Subjects--CCQ Score Day 10
n=3 Participants
CCQ-45 scores from day 10 in female subjects (they took CLAV 500mg/3 for the first 3 days, then 750 mg/day for days for 3 days and 1000mg/day for 4 days) minus the baseline scores.
|
Femaile PBO Subjects--CCQ Scores Day 10
n=1 Participants
The CCQ scores day 10 minus the baseline scores in female submects who took matched PBO for 10 days.
|
|---|---|---|---|---|
|
Craving
|
7 difference in score on a scale
Standard Deviation 16
|
-22 difference in score on a scale
Standard Deviation 10
|
-15 difference in score on a scale
Standard Deviation 21
|
49 difference in score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Brain glutamine will be analyzed at baseline (Day 1 prior to CLAV or PBO dose) and at Day 10 day (having completed Periods 1, 2 and 3 (CLAV 500mg/day for 3 days, 750 mg/day for 3 days and 1000 mg/day for 4 days).Change in brain glutamine (Gln) concentration in the ACC at Day 10 compared to baseline as assessed by MRS in the ACC.
Outcome measures
| Measure |
Clavulanic Acid Day 10
n=9 Participants
9 participants who completed Periods 1, 2 and 3 were assessed for brain Glutamate levels in the ACC using MRS at the end of Period 3 (Day 10.)This measure was correlated with CCQ on day 10 adjusted for the baseline.
|
Clavulanic Acid Baseline
n=9 Participants
Same 9 subjects underwent CCQ and MRS on Day 1 prior to receiving CLAV 500 mg.
|
Female CLAV Subjects--CCQ Score Day 10
n=3 Participants
CCQ-45 scores from day 10 in female subjects (they took CLAV 500mg/3 for the first 3 days, then 750 mg/day for days for 3 days and 1000mg/day for 4 days) minus the baseline scores.
|
Femaile PBO Subjects--CCQ Scores Day 10
n=3 Participants
The CCQ scores day 10 minus the baseline scores in female submects who took matched PBO for 10 days.
|
|---|---|---|---|---|
|
Change in Brain Glutamine From Baseline
|
1.5 mmol/kg
Standard Deviation 1.0
|
2.1 mmol/kg
Standard Deviation 2.0
|
0.8 mmol/kg
Standard Deviation 0.3
|
0.7 mmol/kg
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 1-24 days (during and up to 2 weeks after study dosing period)Population: see adverse events report; Blood Pressure, heart rate, EKG were not statistically different between the two groups.
Adverse events (AES) will be defined as any clinically significant changes in vital signs, clinically significant change in Electrocardiogram (EKG) from baseline measurement, clinically significant changes in laboratory bloodwork (Complete blood count, comprehensive metabolic panel, urinalysis), or any self reported side effects compared with baseline. AEs will be collected throughout the study and reviewed by a physician. An evaluation of AE severity (mild, moderate, severe) will be evaluated by a physician based on participant self-report. AEs per subject will be listed by organ system, and the number of AEs within the subject population will be totaled.
Outcome measures
| Measure |
Clavulanic Acid Day 10
n=10 Participants
9 participants who completed Periods 1, 2 and 3 were assessed for brain Glutamate levels in the ACC using MRS at the end of Period 3 (Day 10.)This measure was correlated with CCQ on day 10 adjusted for the baseline.
|
Clavulanic Acid Baseline
n=3 Participants
Same 9 subjects underwent CCQ and MRS on Day 1 prior to receiving CLAV 500 mg.
|
Female CLAV Subjects--CCQ Score Day 10
CCQ-45 scores from day 10 in female subjects (they took CLAV 500mg/3 for the first 3 days, then 750 mg/day for days for 3 days and 1000mg/day for 4 days) minus the baseline scores.
|
Femaile PBO Subjects--CCQ Scores Day 10
The CCQ scores day 10 minus the baseline scores in female submects who took matched PBO for 10 days.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events (AEs)
|
6 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
Clavulanic Acid Treatment Period 1-500mg/Day
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CLavulanic Acid Treatment Period 2-750mg.Day
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Clavulanic Acid Treatment Period 3--1000mg/Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clavulanic Acid Treatment Period 1-500mg/Day
n=10 participants at risk
10 Participants will be treated with CLAV (500mg/day for 3 days)
|
CLavulanic Acid Treatment Period 2-750mg.Day
n=9 participants at risk
9 Participants who completed Period 1 treated with CLAV (750mg/day for 3 days)
|
Clavulanic Acid Treatment Period 3--1000mg/Day
n=9 participants at risk
9 Participants who completed Period 1 treated with CLAV (1000mg/day for 3 days)
|
Placebo
n=3 participants at risk
3 participants received matched placebo. They will be given additional placebo capsules to match the number given to the CLAV group.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
33.3%
3/9 • Number of events 3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
33.3%
1/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Gastrointestinal disorders
flatulence
|
10.0%
1/10 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
33.3%
1/3 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Gastrointestinal disorders
loose stool
|
10.0%
1/10 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
33.3%
1/3 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Gastrointestinal disorders
stomach pain
|
0.00%
0/10 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 2 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
33.3%
1/3 • Number of events 2 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
1/10 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Hepatobiliary disorders
Elevated Liver Function Tests
|
10.0%
1/10 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Vascular disorders
High blood pressure
|
10.0%
1/10 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/10 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 2 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Skin and subcutaneous tissue disorders
Swollen feet
|
0.00%
0/10 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Nervous system disorders
Lightheaded
|
0.00%
0/10 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/10 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
11.1%
1/9 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
33.3%
1/3 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
|
Reproductive system and breast disorders
Priapism
|
10.0%
1/10 • Number of events 1 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/9 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
0.00%
0/3 • 24 days
9 subjects in the CLAV group and 3 subjects in the PBO group will be assessed throughout the study for Adverse Events (AE). Subjects in the CLAV group are treated in 3 periods: CLAV 500 mg for 3 days, 750mg for the next 3 days and then 1000mg for the last 4 days to complete the 10 days of the study. AEs were reported by period/dose though the same person may have had several AE or the same AE at different doses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place