Trial Outcomes & Findings for The Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Participants With Osteoarthritis (MK-0663-168) (NCT NCT01980940)
NCT ID: NCT01980940
Last Updated: 2024-06-27
Results Overview
Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application
Results posted on
2024-06-27
Participant Flow
Participants were screened for inclusion in the study over 4 weeks prior to first treatment. Two additional participants were screened for Study Part 1 but not randomized or treated due to screen failure.
Participant milestones
| Measure |
Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
|
Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
|
Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: Placebo (Deviation)
Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
|
Pt 2: ETOR 50 DMSO
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Pt 2: Placebo
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
3
|
2
|
2
|
24
|
24
|
|
Overall Study
Treated
|
5
|
5
|
5
|
3
|
2
|
2
|
24
|
24
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
3
|
2
|
0
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
|
Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
|
Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: Placebo (Deviation)
Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
|
Pt 2: ETOR 50 DMSO
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Pt 2: Placebo
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
The Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Participants With Osteoarthritis (MK-0663-168)
Baseline characteristics by cohort
| Measure |
Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO
n=5 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
|
Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG
n=5 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO
n=5 Participants
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
|
Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO
n=3 Participants
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG
n=2 Participants
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
|
Pt 1: Placebo (Deviation)
n=2 Participants
Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
|
Pt 2: ETOR 50 DMSO
n=24 Participants
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Pt 2: Placebo
n=24 Participants
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
55.0 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
60.5 years
STANDARD_DEVIATION 4.9 • n=8 Participants
|
61.5 years
STANDARD_DEVIATION 8.2 • n=8 Participants
|
61.2 years
STANDARD_DEVIATION 6.7 • n=24 Participants
|
61.3 years
STANDARD_DEVIATION 7.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
48 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-applicationPopulation: PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Cmax) without any protocol violation that interferes with PK data interpretation
Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).
Outcome measures
| Measure |
ETOR 75 DMSO
n=20 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=20 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
n=20 Participants
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
n=18 Participants
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing
|
12.39 mg
90% Confidence Interval 8.24 • Interval 9.95 to 15.43
|
2.43 mg
90% Confidence Interval 2.14 • Interval 1.83 to 3.24
|
27.30 mg
90% Confidence Interval 15.30 • Interval 22.76 to 32.75
|
3.74 mg
90% Confidence Interval 3.79 • Interval 3.0 to 4.66
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-applicationPopulation: PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Tmax) without any protocol violation that interferes with PK data interpretation
Tmax determined for the period up to 72 hours post-single application.
Outcome measures
| Measure |
ETOR 75 DMSO
n=20 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=18 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
n=20 Participants
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
n=18 Participants
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
n=2 Participants
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Part 1: Time to Maximum Concentration (Tmax) of ETOR After Single Dosing
|
30.0 hour
Interval 23.5 to 72.0
|
48.0 hour
Interval 1.0 to 72.0
|
24.0 hour
Interval 2.0 to 72.0
|
48 hour
Interval 24.0 to 72.0
|
36.0 hour
Interval 24.0 to 48.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-applicationPopulation: PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (AUC0-last) without any protocol violation that interferes with PK data interpretation
Area under the observed concentration-time curve from time zero to the last quantifiable time point determined for the period up to 72 hours post-single application. The area was calculated according to the linear up/log down trapezoidal rule. AUC0-last is an estimate of total plasma exposure. Descriptive statistics are expressed as the GLSM. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).
Outcome measures
| Measure |
ETOR 75 DMSO
n=20 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=20 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
n=20 Participants
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
n=18 Participants
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Part 1: Area Under the Concentration-time Curve of ETOR From Time 0 to Last (AUC0-last) After Single Dosing
|
611.3 mg
90% Confidence Interval 400.97 • Interval 493.9 to 756.6
|
65.6 mg
90% Confidence Interval 112.83 • Interval 30.7 to 140.0
|
1309.7 mg
90% Confidence Interval 686.34 • Interval 1086.0 to 1579.5
|
161.3 mg
90% Confidence Interval 172.96 • Interval 122.3 to 212.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14Population: Full analysis set (FAS) defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment
The WOMAC VA 3.1 Pain subscale is a self-administered questionnaire assessing lower extremity pain due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Pain Subscale had five questions with answers to each item assessed on a 100 mm VA scale (0 = no pain; 100 = extreme pain). The score for each item was summed and the overall score ranged from 0 to 500 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in pain.
Outcome measures
| Measure |
ETOR 75 DMSO
n=24 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=24 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale
BL to Day 2
|
-24.21 Units on a scale
Standard Deviation 76.88
|
-37.21 Units on a scale
Standard Deviation 101.77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale
BL to Day 11
|
-59.42 Units on a scale
Standard Deviation 71.12
|
-63.60 Units on a scale
Standard Deviation 90.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale
BL to Day 14
|
-69.60 Units on a scale
Standard Deviation 75.81
|
-72.60 Units on a scale
Standard Deviation 91.35
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale
BL to Day 4
|
-34.29 Units on a scale
Standard Deviation 69.15
|
-43.92 Units on a scale
Standard Deviation 94.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale
BL to Day 7
|
-45.81 Units on a scale
Standard Deviation 67.92
|
-54.11 Units on a scale
Standard Deviation 94.11
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14Population: FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment
The WOMAC VA 3.1 Stiffness subscale is a self-administered questionnaire assessing lower extremity stiffness due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Stiffness subscale had two questions with answers to each item assessed on a 100 mm VA scale (0 = no stiffness; 100 = extreme stiffness). The score for each item was summed and the overall score ranged from 0 to 200 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in stiffness.
Outcome measures
| Measure |
ETOR 75 DMSO
n=24 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=24 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale
BL to Day 2
|
-9.17 Units on a scale
Standard Deviation 37.44
|
-16.79 Units on a scale
Standard Deviation 41.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale
BL to Day 7
|
-19.34 Units on a scale
Standard Deviation 35.75
|
-23.08 Units on a scale
Standard Deviation 37.53
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale
BL to Day 14
|
-29.22 Units on a scale
Standard Deviation 36.64
|
-30.52 Units on a scale
Standard Deviation 34.33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale
BL to Day 4
|
-14.69 Units on a scale
Standard Deviation 35.23
|
-18.79 Units on a scale
Standard Deviation 39.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale
BL to Day 11
|
-24.44 Units on a scale
Standard Deviation 34.60
|
-26.87 Units on a scale
Standard Deviation 35.26
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14Population: FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment
The WOMAC VA 3.1 Physical Functioning subscale is a self-administered questionnaire assessing lower extremity physical function due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Physical Functioning subscale had 17 questions with answers to each item assessed on a 100 mm VA scale (0 = no difficulty; 100 = extreme difficulty). The score for each item was summed and the overall score ranged from 0 to 1700 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in physical function.
Outcome measures
| Measure |
ETOR 75 DMSO
n=24 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=24 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale
BL to Day 14
|
-250.82 Units on a scale
Standard Deviation 218.72
|
-280.29 Units on a scale
Standard Deviation 233.39
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale
BL to Day 2
|
-117.13 Units on a scale
Standard Deviation 200.38
|
-153.54 Units on a scale
Standard Deviation 278.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale
BL to Day 4
|
-147.71 Units on a scale
Standard Deviation 183.07
|
-171.35 Units on a scale
Standard Deviation 272.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale
BL to Day 7
|
-172.94 Units on a scale
Standard Deviation 186.22
|
-199.88 Units on a scale
Standard Deviation 265.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale
BL to Day 11
|
-214.87 Units on a scale
Standard Deviation 203.95
|
-245.05 Units on a scale
Standard Deviation 238.05
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2, Day 4, Day 7, Day 11, Day 14, post-trial (up to Day 28)Population: FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment
The PGART is a self-administered questionnaire completed by participants. Participant assessment of response of arthritis to study medication was assessed on a 5-point Likert scale ('very well', 'well', 'fair', 'poor', and 'very poor').
Outcome measures
| Measure |
ETOR 75 DMSO
n=24 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=24 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Post-trial: Well
|
62.5 Percentage of participants
|
50.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Post-trial: Fair
|
29.2 Percentage of participants
|
29.2 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 11: Poor
|
16.7 Percentage of participants
|
12.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 11: Very poor
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 14: Well
|
54.2 Percentage of participants
|
50.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 14: Fair
|
41.7 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 14: Poor
|
4.2 Percentage of participants
|
8.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 14: Very poor
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Post-trial: Very well
|
8.3 Percentage of participants
|
8.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 2: Very well
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 2: Well
|
20.8 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 2: Fair
|
25.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 2: Poor
|
37.5 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 2: Very poor
|
16.7 Percentage of participants
|
8.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 4: Very well
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 4: Well
|
20.8 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 4: Fair
|
45.8 Percentage of participants
|
37.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 4: Poor
|
29.2 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 4: Very poor
|
4.2 Percentage of participants
|
4.2 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 7: Very well
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 7: Well
|
25.0 Percentage of participants
|
37.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 7: Fair
|
50.0 Percentage of participants
|
37.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 7: Poor
|
25.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 7: Very poor
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 11: Very well
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 11: Well
|
37.5 Percentage of participants
|
50.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 11: Fair
|
45.8 Percentage of participants
|
37.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Day 14: Very well
|
0.0 Percentage of participants
|
8.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Post-trial: Poor
|
0 Percentage of participants
|
12.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Post-trial: Very poor
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Part 1: up to Day 47; Study Part 2: up to Day 28Population: Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Outcome measures
| Measure |
ETOR 75 DMSO
n=20 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=20 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
n=20 Participants
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
n=18 Participants
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
n=2 Participants
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
n=2 Participants
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
n=24 Participants
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
n=24 Participants
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Study Part 1: up to Day 47; Study Part 2: up to Day 28Population: Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Outcome measures
| Measure |
ETOR 75 DMSO
n=20 Participants
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG
n=20 Participants
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO
n=20 Participants
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG
n=18 Participants
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD
n=2 Participants
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
n=2 Participants
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
n=24 Participants
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
n=24 Participants
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Study Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
ETOR 75 DMSO (Pt 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ETOR 75 PG (Pt 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ETOR 150 DMSO (Pt 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ETOR 150 PG (Pt 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ETOR OD (Pt 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Pt 1) (Deviation)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ETOR 50 DMSO (Pt 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Pt 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ETOR 75 DMSO (Pt 1)
n=20 participants at risk
Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
|
ETOR 75 PG (Pt 1)
n=20 participants at risk
Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
|
ETOR 150 DMSO (Pt 1)
n=20 participants at risk
Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
|
ETOR 150 PG (Pt 1)
n=18 participants at risk
Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
|
ETOR OD (Pt 1)
n=2 participants at risk
Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
|
Placebo (Pt 1) (Deviation)
n=2 participants at risk
Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
|
ETOR 50 DMSO (Pt 2)
n=24 participants at risk
Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
|
Placebo (Pt 2)
n=24 participants at risk
Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/18 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
4.2%
1/24 • Number of events 1 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
8.3%
2/24 • Number of events 2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
5.6%
1/18 • Number of events 1 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/24 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/24 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/18 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
8.3%
2/24 • Number of events 2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/24 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/20 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/18 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
2/2 • Number of events 2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/2 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/24 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/24 • Study Part 1: up to Day 47; Study Part 2: up to Day 28
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER