Background
Methods
Study design
Patients
Efficacy and safety measures
Statistical analyses
Results
Patient disposition
Baseline demographic and clinical characteristics
Variable | DLX_DLX | PLA_DLX |
---|---|---|
N = 166 | N = 176 | |
Age, years, mean (SD) | 61.2 (8.0) | 60.0 (8.3) |
Gender, n (%) | ||
Female | 130 (78.3) | 130 (73.9) |
BMI, kg/m2, mean (SD) | 25.5 (3.2) | 25.3 (3.6) |
Location of OA, n (%) | ||
Hip | 0 | 1 (0.6) |
Knee | 166 (100.0) | 175 (99.4) |
Duration of OA pain, years, mean (SD) | 7.7 (6.6) | 7.6 (6.9) |
BPI 24-h average pain, mean (SD) | 5.6 (1.3) | 5.5 (1.2) |
BPI–Interference average rating, mean (SD) | 3.6 (2.0) | 3.6 (1.9) |
Concomitant analgesics
Efficacy
Variable | DLX_DLX | PLA_DLX | ||
---|---|---|---|---|
N = 166 | N = 175 | |||
Baseline | Change | Baseline | Change | |
Average pain | 3.3 (1.8) | −1.0 (1.7)*** | 3.7 (1.8) | −1.4 (1.6)*** |
Worst pain | 4.2 (2.1) | −1.1 (2.0)*** | 4.8 (1.9) | −1.6 (1.7)*** |
Least pain | 2.2 (1.9) | −0.9 (1.6)*** | 2.5 (1.9) | −1.0 (1.7)*** |
Right now pain | 2.8 (2.1) | −1.1 (1.7)*** | 3.3 (2.1) | −1.4 (1.7)*** |
Average Interference | 1.9 (1.8) | −0.6 (1.1)*** | 2.2 (1.7) | −0.8 (1.2)*** |
General activity | 3.0 (2.3) | −0.9 (1.9)*** | 3.6 (2.2) | −1.3 (1.9)*** |
Mood | 1.2 (2.0) | −0.4 (1.2)*** | 1.6 (2.1) | −0.6 (1.7)*** |
Walking ability | 3.0 (2.2) | −0.9 (1.6)*** | 3.5 (2.2) | −1.3 (1.7)*** |
Normal work | 2.6 (2.3) | −0.9 (1.8)*** | 3.1 (2.2) | −1.1 (1.9)*** |
Relations with other people | 0.8 (1.8) | −0.2 (1.1)** | 0.9 (1.7) | −0.3 (1.2)** |
Sleep | 1.3 (2.2) | −0.5 (1.7)*** | 1.5 (2.1) | −0.5 (1.6)*** |
Enjoyment of life | 1.2 (2.1) | −0.5 (1.5)*** | 1.2 (2.0) | −0.5 (1.6)*** |
Safety
Adverse Event, n (%) | DLX_DLX | PLA_DLX |
---|---|---|
N = 166 | N = 175 | |
Patients with ≥1 TEAE | 42 (25.3) | 81 (46.3) |
Dry mouth | 3 (1.8) | 15 (8.6) |
Somnolence | 4 (2.4) | 10 (5.7) |
Alanine aminotransferase increased | 3 (1.8) | 10 (5.7) |
Nausea | 5 (3.0) | 8 (4.6) |
Aspartate aminotransferase increased | 1 (0.6) | 8 (4.6) |
Dizziness | 3 (1.8) | 7 (4.0) |
Constipation | 1 (0.6) | 7 (4.0) |
Weight decreased | 0 | 4 (2.3) |