Trial Outcomes & Findings for CBD for Dental Pain (NCT NCT04642404)
NCT ID: NCT04642404
Last Updated: 2024-05-09
Results Overview
Patients will report their pain level using a 100mm Visual Analogue Scale at baseline, measured at baseline and 180 minutes. Score is measured on a 100mm scale, scored 0-100, with a lower score indicating less pain.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Baseline to 180 minutes
Results posted on
2024-05-09
Participant Flow
The study population consisted of adult patients 18 to 75 y old, presenting at the UT Health School of Dentistry, San Antonio, Texas, with moderate to severe odontogenic pain, defined as ≥30 mm on a 100-mm visual analog scale (VAS)
Participant milestones
| Measure |
Epidiolex 10mg/kg Single Dose
After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Epidiolex 20mg/kg Single Dose
The 20mg/kg dose is the maximum recommended daily dose from the manufacturer. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Placebo Group
Placebo drug will be a solution with the same taste, texture and color as the drug. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Placebo: Placebo drug will be a solution with the same taste, texture and color as the drug.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CBD for Dental Pain
Baseline characteristics by cohort
| Measure |
Epidiolex 10mg/kg Single Dose
n=20 Participants
After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Epidiolex 20mg/kg Single Dose
n=20 Participants
The 20mg/kg dose is the maximum recommended daily dose from the manufacturer. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Placebo Group
n=21 Participants
Placebo drug will be a solution with the same taste, texture and color as the drug. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Placebo: Placebo drug will be a solution with the same taste, texture and color as the drug.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 12.66 • n=5 Participants
|
44.75 years
STANDARD_DEVIATION 11.61 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 16.78 • n=5 Participants
|
44.15 years
STANDARD_DEVIATION 13.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
21 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Weight
|
94.37 Kg
STANDARD_DEVIATION 21.04 • n=5 Participants
|
87.71 Kg
STANDARD_DEVIATION 22.21 • n=7 Participants
|
92.43 Kg
STANDARD_DEVIATION 22.7 • n=5 Participants
|
91.50 Kg
STANDARD_DEVIATION 21.98 • n=4 Participants
|
|
Body Mass Index (BMI)
|
33.5 kg/m^2
STANDARD_DEVIATION 6.42 • n=5 Participants
|
33.32 kg/m^2
STANDARD_DEVIATION 6.63 • n=7 Participants
|
32.32 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
33.04 kg/m^2
STANDARD_DEVIATION 6.18 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 180 minutesPatients will report their pain level using a 100mm Visual Analogue Scale at baseline, measured at baseline and 180 minutes. Score is measured on a 100mm scale, scored 0-100, with a lower score indicating less pain.
Outcome measures
| Measure |
Epidiolex 10mg/kg Single Dose
n=20 Participants
After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Epidiolex 20mg/kg Single Dose
n=20 Participants
The 20mg/kg dose is the maximum recommended daily dose from the manufacturer. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Placebo Group
n=21 Participants
Placebo drug will be a solution with the same taste, texture and color as the drug. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Placebo: Placebo drug will be a solution with the same taste, texture and color as the drug.
|
|---|---|---|---|
|
Intra-group VAS Pain Intensity and Maximum Pain Relief
Baseline
|
63 score on a scale
Interval 51.5 to 79.5
|
69 score on a scale
Interval 59.0 to 76.25
|
63 score on a scale
Interval 51.7 to 73.5
|
|
Intra-group VAS Pain Intensity and Maximum Pain Relief
180 minutes
|
21 score on a scale
Interval 1.0 to 38.0
|
20 score on a scale
Interval 4.5 to 39.2
|
48 score on a scale
Interval 13.0 to 58.7
|
PRIMARY outcome
Timeframe: Baseline, 90 minutes and 180 minutesBite force is measured by biting down on the Bite Fork at various times to measure change in value. The digital bite transducer is a previously validated instrument used to assess changes in the bite forces (N) before and after the intervention.
Outcome measures
| Measure |
Epidiolex 10mg/kg Single Dose
n=20 Participants
After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Epidiolex 20mg/kg Single Dose
n=20 Participants
The 20mg/kg dose is the maximum recommended daily dose from the manufacturer. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Placebo Group
n=21 Participants
Placebo drug will be a solution with the same taste, texture and color as the drug. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Placebo: Placebo drug will be a solution with the same taste, texture and color as the drug.
|
|---|---|---|---|
|
Bite Force Measurement
90 minutes
|
86 Newtons
Interval 56.0 to 135.0
|
59 Newtons
Interval 35.7 to 78.7
|
66 Newtons
Interval 44.5 to 73.5
|
|
Bite Force Measurement
180 minutes
|
80 Newtons
Interval 68.0 to 135.0
|
66 Newtons
Interval 43.0 to 82.0
|
65 Newtons
Interval 43.0 to 87.5
|
|
Bite Force Measurement
Baseline
|
61 Newtons
Interval 42.5 to 100.0
|
53 Newtons
Interval 32.5 to 60.0
|
54 Newtons
Interval 32.5 to 74.5
|
SECONDARY outcome
Timeframe: 3 hours and 7 DaysPopulation: All subjects enrolled, regardless of whether they completed the study. Adverse effects were self reported. Some subjects were lost to follow up for the 7 day self assessment, so did not complete the self assessment.
Included: Psychoactive effects, mood changes, and report other side effects after single dose of Epidiolex
Outcome measures
| Measure |
Epidiolex 10mg/kg Single Dose
n=21 Participants
After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Epidiolex 20mg/kg Single Dose
n=20 Participants
The 20mg/kg dose is the maximum recommended daily dose from the manufacturer. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Placebo Group
n=23 Participants
Placebo drug will be a solution with the same taste, texture and color as the drug. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Placebo: Placebo drug will be a solution with the same taste, texture and color as the drug.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
3 hour
|
9 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
7 day
|
2 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Epidiolex 10mg/kg Single Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Epidiolex 20mg/kg Single Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epidiolex 10mg/kg Single Dose
n=21 participants at risk
After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Epidiolex 20mg/kg Single Dose
n=20 participants at risk
The 20mg/kg dose is the maximum recommended daily dose from the manufacturer. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Epidiolex 100 mg/mL Oral Solution: Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
|
Placebo Group
n=23 participants at risk
Placebo drug will be a solution with the same taste, texture and color as the drug. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Placebo: Placebo drug will be a solution with the same taste, texture and color as the drug.
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
14.3%
3/21 • Number of events 4 • Adverse events were reported at 3 hours and at 7 days
|
15.0%
3/20 • Number of events 3 • Adverse events were reported at 3 hours and at 7 days
|
8.7%
2/23 • Number of events 2 • Adverse events were reported at 3 hours and at 7 days
|
|
General disorders
Sedation
|
28.6%
6/21 • Number of events 7 • Adverse events were reported at 3 hours and at 7 days
|
15.0%
3/20 • Number of events 3 • Adverse events were reported at 3 hours and at 7 days
|
4.3%
1/23 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
|
General disorders
Headache
|
9.5%
2/21 • Number of events 2 • Adverse events were reported at 3 hours and at 7 days
|
5.0%
1/20 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/23 • Adverse events were reported at 3 hours and at 7 days
|
|
Gastrointestinal disorders
Decreased appetite
|
9.5%
2/21 • Number of events 2 • Adverse events were reported at 3 hours and at 7 days
|
5.0%
1/20 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/23 • Adverse events were reported at 3 hours and at 7 days
|
|
General disorders
Abnormal behavior
|
0.00%
0/21 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/20 • Adverse events were reported at 3 hours and at 7 days
|
4.3%
1/23 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2 • Adverse events were reported at 3 hours and at 7 days
|
5.0%
1/20 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/23 • Adverse events were reported at 3 hours and at 7 days
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
3/21 • Number of events 3 • Adverse events were reported at 3 hours and at 7 days
|
35.0%
7/20 • Number of events 7 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/23 • Adverse events were reported at 3 hours and at 7 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • Adverse events were reported at 3 hours and at 7 days
|
15.0%
3/20 • Number of events 3 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/23 • Adverse events were reported at 3 hours and at 7 days
|
|
General disorders
Abdominal pain
|
4.8%
1/21 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
20.0%
4/20 • Number of events 8 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/23 • Adverse events were reported at 3 hours and at 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
4.8%
1/21 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/20 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/23 • Adverse events were reported at 3 hours and at 7 days
|
|
General disorders
Fatigue
|
14.3%
3/21 • Number of events 4 • Adverse events were reported at 3 hours and at 7 days
|
20.0%
4/20 • Number of events 6 • Adverse events were reported at 3 hours and at 7 days
|
4.3%
1/23 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
|
General disorders
Dry mouth
|
4.8%
1/21 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/20 • Adverse events were reported at 3 hours and at 7 days
|
4.3%
1/23 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
|
Nervous system disorders
Paresthesia
|
4.8%
1/21 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/20 • Adverse events were reported at 3 hours and at 7 days
|
4.3%
1/23 • Number of events 2 • Adverse events were reported at 3 hours and at 7 days
|
|
Blood and lymphatic system disorders
Hot Flashes
|
4.8%
1/21 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/20 • Adverse events were reported at 3 hours and at 7 days
|
4.3%
1/23 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
|
Cardiac disorders
Angina
|
4.8%
1/21 • Number of events 1 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/20 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/23 • Adverse events were reported at 3 hours and at 7 days
|
|
Eye disorders
Double vision
|
0.00%
0/21 • Adverse events were reported at 3 hours and at 7 days
|
0.00%
0/20 • Adverse events were reported at 3 hours and at 7 days
|
4.3%
1/23 • Number of events 2 • Adverse events were reported at 3 hours and at 7 days
|
Additional Information
Vanessa Chrepa, DDS
University of Texas Health Science Center at San Antonio
Phone: 210-459-3601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place