Table 2.
Changes in pain intensity during treatment with oral methylnaltrexone
| Characteristics | Oral methylnaltrexone
|
Placebo (n=201) | ||
|---|---|---|---|---|
| 150 mg (n=201) | 300 mg (n=201) | 450 mg (n=200) | ||
| Day 14 | ||||
| Mean score (SD) | 6.3 (1.9) | 6.2 (2.1) | 6.4 (1.9) | 6.1 (2.0) |
| Mean change from baseline | −0.1 | −0.1 | 0.0 | −0.1 |
| Change vs placeboa (95% CI) | 0.0 (−0.3, 0.3) | 0.0 (−0.3, 0.4) | 0.2 (−0.2, 0.5) | |
| P-value | 0.9 | 0.8 | 0.3 | |
| Day 28 | ||||
| Mean score (SD) | 6.4 (1.8) | 6.5 (2.0) | 6.3 (1.9) | 6.1 (2.0) |
| Mean change from baseline | 0.1 | 0.1 | 0 | –0.1 |
| Change vs placeboa (95% CI) | 0.2 (−0.1, 0.5) | 0.3 (−0.1, 0.6) | 0.1 (−0.2, 0.4) | |
| P-value | 0.2 | 0.1 | 0.5 | |
| Day 42 | ||||
| Mean score (SD) | 6.4 (1.9) | 6.3 (2.0) | 6.4 (1.9) | 6.2 (2.0) |
| Mean change from baseline | 0 | −0.1 | −0.1 | −0.1 |
| Change vs placeboa (95% CI) | 0.1 (−0.3, 0.5) | 0 (–0.3, 0.4) | 0 (−0.3, 0.4) | |
| P-value | 0.6 | >0.9 | 0.9 | |
| Day 56 | ||||
| Mean score (SD) | 6.4 (1.9) | 6.5 (1.9) | 6.4 (2.0) | 6.3 (1.9) |
| Mean change from baseline | 0 | 0.1 | 0 | 0 |
| Change vs placeboa (95% CI) | 0 (−0.3, 0.4) | 0.2 (−0.2, 0.5) | 0 (−0.4, 0.4) | |
| P-value | 0.8 | 0.4 | >0.9 | |
| Day 84 | ||||
| Mean score (SD) | 6.3 (1.9) | 6.5 (1.9) | 6.3 (2.0) | 6.2 (2.0) |
| Mean change from baseline | 0 | 0.1 | 0 | −0.1 |
| Change vs placeboa (95% CI) | 0.1 (−0.3, 0.5) | 0.2 (−0.1, 0.6) | 0.1 (−0.3, 0.4) | |
| P-value | 0.6 | 0.2 | 0.7 | |
Notes:
a
Value reflects least-squares mean difference vs placebo.