Trial Outcomes & Findings for A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale (NCT NCT03570554)
NCT ID: NCT03570554
Last Updated: 2020-06-19
Results Overview
Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness. This endpoint was calculated by summing the changes from baseline (CFB) in BASS scores at Days 2, 3, and 4 of the treatment periods.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
4 days
Results posted on
2020-06-19
Participant Flow
Study was conducted at multiple centers in the US between 29 June 2018 (first participant first visit) and 14 June 2019 (last participant last visit).
Overall, 209 participants were screened. Of them, 168 participants were screen failures, and 41 subjects were randomized to study treatments.
Participant milestones
| Measure |
Treatment A-D-C-B
Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by placebo for 4 days; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment B-C-D-A
Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by placebo for 4 days; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment C-A-B-D
Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by placebo for 4 days. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment D-B-A-C
Participants received placebo for 4 days; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Treatment A-D-C-B
Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by placebo for 4 days; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment B-C-D-A
Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by placebo for 4 days; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment C-A-B-D
Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by placebo for 4 days. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment D-B-A-C
Participants received placebo for 4 days; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
|---|---|---|---|---|
|
Overall Study
Non-compliance with study drug
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Participants in safety population with evaluable data for this characteristic
Baseline characteristics by cohort
| Measure |
Treatment A-D-C-B
n=10 Participants
Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by placebo for 4 days; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment B-C-D-A
n=10 Participants
Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by placebo for 4 days; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment C-A-B-D
n=11 Participants
Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by placebo for 4 days. Treatment periods were separated by a washout period of 3 to 7 days.
|
Treatment D-B-A-C
n=10 Participants
Participants received placebo for 4 days; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.4 Years
STANDARD_DEVIATION 9.20 • n=10 Participants
|
61.3 Years
STANDARD_DEVIATION 8.77 • n=10 Participants
|
61.6 Years
STANDARD_DEVIATION 7.55 • n=11 Participants
|
59.6 Years
STANDARD_DEVIATION 8.28 • n=10 Participants
|
61.2 Years
STANDARD_DEVIATION 8.19 • n=41 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
7 Participants
n=10 Participants
|
33 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=11 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=11 Participants
|
9 Participants
n=10 Participants
|
37 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=11 Participants
|
5 Participants
n=10 Participants
|
16 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=11 Participants
|
5 Participants
n=10 Participants
|
24 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=41 Participants
|
|
Brief Arthritis Stiffness Scale (BASS)
Treatment period 1
|
26.7 Scores on a scale
STANDARD_DEVIATION 4.90 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
25.8 Scores on a scale
STANDARD_DEVIATION 5.05 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
27.8 Scores on a scale
STANDARD_DEVIATION 5.56 • n=11 Participants • Participants in safety population with evaluable data for this characteristic
|
23.1 Scores on a scale
STANDARD_DEVIATION 5.35 • n=9 Participants • Participants in safety population with evaluable data for this characteristic
|
26.0 Scores on a scale
STANDARD_DEVIATION 5.31 • n=40 Participants • Participants in safety population with evaluable data for this characteristic
|
|
Brief Arthritis Stiffness Scale (BASS)
Treatment period 2
|
25.8 Scores on a scale
STANDARD_DEVIATION 7.74 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
21.8 Scores on a scale
STANDARD_DEVIATION 8.32 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
22.3 Scores on a scale
STANDARD_DEVIATION 9.74 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
25.3 Scores on a scale
STANDARD_DEVIATION 4.64 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
23.8 Scores on a scale
STANDARD_DEVIATION 7.74 • n=40 Participants • Participants in safety population with evaluable data for this characteristic
|
|
Brief Arthritis Stiffness Scale (BASS)
Treatment period 3
|
26.3 Scores on a scale
STANDARD_DEVIATION 5.56 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
17.7 Scores on a scale
STANDARD_DEVIATION 10.03 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
22.9 Scores on a scale
STANDARD_DEVIATION 10.29 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
24.0 Scores on a scale
STANDARD_DEVIATION 6.48 • n=9 Participants • Participants in safety population with evaluable data for this characteristic
|
22.7 Scores on a scale
STANDARD_DEVIATION 8.69 • n=39 Participants • Participants in safety population with evaluable data for this characteristic
|
|
Brief Arthritis Stiffness Scale (BASS)
Treatment period 4
|
21.9 Scores on a scale
STANDARD_DEVIATION 10.56 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
20.3 Scores on a scale
STANDARD_DEVIATION 6.40 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
24.2 Scores on a scale
STANDARD_DEVIATION 9.95 • n=10 Participants • Participants in safety population with evaluable data for this characteristic
|
23.8 Scores on a scale
STANDARD_DEVIATION 7.92 • n=9 Participants • Participants in safety population with evaluable data for this characteristic
|
22.5 Scores on a scale
STANDARD_DEVIATION 8.68 • n=39 Participants • Participants in safety population with evaluable data for this characteristic
|
PRIMARY outcome
Timeframe: 4 daysPopulation: Per-protocol (PP) population: all subjects who were randomly assigned and had taken at least one dose of IMP without major protocol violations that could affect the evaluability of the primary efficacy parameter.
Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness. This endpoint was calculated by summing the changes from baseline (CFB) in BASS scores at Days 2, 3, and 4 of the treatment periods.
Outcome measures
| Measure |
Naproxen
n=37 Participants
Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day.
|
Acetaminophen ER
n=37 Participants
Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day.
|
Celecoxib
n=37 Participants
Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day.
|
Placebo
n=36 Participants
Participants received placebo for 4 days.
|
|---|---|---|---|---|
|
Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period
|
-12.6 Scores on a scale
Standard Error 5.46
|
-13.6 Scores on a scale
Standard Error 5.46
|
-11.7 Scores on a scale
Standard Error 5.46
|
-2.3 Scores on a scale
Standard Error 5.47
|
SECONDARY outcome
Timeframe: 4 daysPopulation: Per-protocol (PP) population: all subjects who were randomly assigned and had taken at least one dose of IMP without major protocol violations that could affect the evaluability of the primary efficacy parameter.
Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness.
Outcome measures
| Measure |
Naproxen
n=37 Participants
Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day.
|
Acetaminophen ER
n=37 Participants
Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day.
|
Celecoxib
n=37 Participants
Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day.
|
Placebo
n=36 Participants
Participants received placebo for 4 days.
|
|---|---|---|---|---|
|
Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point
Day 2
|
20.8 Scores on a scale
Standard Error 1.62
|
19.7 Scores on a scale
Standard Error 1.62
|
20.6 Scores on a scale
Standard Error 1.62
|
23.2 Scores on a scale
Standard Error 1.62
|
|
Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point
Day 3
|
18.4 Scores on a scale
Standard Error 1.97
|
18.4 Scores on a scale
Standard Error 1.97
|
18.9 Scores on a scale
Standard Error 1.98
|
22.4 Scores on a scale
Standard Error 1.98
|
|
Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point
Day 4
|
18.1 Scores on a scale
Standard Error 1.97
|
18.0 Scores on a scale
Standard Error 1.97
|
18.5 Scores on a scale
Standard Error 1.97
|
22.0 Scores on a scale
Standard Error 1.97
|
|
Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point
Day 1
|
23.0 Scores on a scale
Standard Error 1.84
|
23.3 Scores on a scale
Standard Error 1.84
|
24.6 Scores on a scale
Standard Error 1.84
|
22.6 Scores on a scale
Standard Error 1.85
|
SECONDARY outcome
Timeframe: Day 4Population: Per-protocol (PP) population: All subjects who were randomly assigned and had taken at least one dose of IMP without major protocol violations that could affect the evaluability of the primary efficacy parameter.
Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness.
Outcome measures
| Measure |
Naproxen
n=37 Participants
Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day.
|
Acetaminophen ER
n=37 Participants
Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day.
|
Celecoxib
n=37 Participants
Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day.
|
Placebo
n=36 Participants
Participants received placebo for 4 days.
|
|---|---|---|---|---|
|
Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4
|
-5.2 Scores on a scale
Standard Error 1.97
|
-5.3 Scores on a scale
Standard Error 1.97
|
-4.8 Scores on a scale
Standard Error 1.97
|
-1.3 Scores on a scale
Standard Error 1.97
|
Adverse Events
Naproxen
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Acetaminophen ER
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Celecoxib
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen
n=39 participants at risk
Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day
|
Acetaminophen ER
n=40 participants at risk
Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day
|
Celecoxib
n=40 participants at risk
Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day
|
Placebo
n=39 participants at risk
Participants received placebo for 4 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
5.0%
2/40 • Number of events 2 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Gastrointestinal disorders
Faeces discoloured
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
General disorders
Chills
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
General disorders
Fatigue
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Investigations
Heart rate decreased
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Nervous system disorders
Tension headache
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/39 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/40 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
2.5%
1/40 • Number of events 1 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
0.00%
0/39 • After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60