Table 5.
Change from baseline in SOWS during RCT double-blind phase
| Treatment (n) | SOWSa
|
|||||||
|---|---|---|---|---|---|---|---|---|
| Without abdominal-cramping-related items
|
With abdominal-cramping-related items
|
|||||||
| Mean score (SD) | Change from baseline (SD) | Change versus placebob (95% CI) | P-value | Mean score (SD) | Change from baseline (SD) | Change versus placebob (95% CI) | P-value | |
| Day 1c | ||||||||
| Methylnaltrexone 12 mg qd (n=143) | 11.5 (10.7) | −2.2 (7.1) | 1.2 (−0.2 to 2.7) | 0.09 | 12.7 (11.4) | −2.1 (7.6) | 1.7 (0.1 to 3.2) | 0.04 |
| Methylnaltrexone 12 mg qod (n=137) | 11.8 (11.9) | −1.7 (7.4) | 1.7 (0.2 to 3.1) | 0.03 | 12.9 (12.7) | −1.5 (8.0) | 2.1 (0.6 to 3.7) | 0.01 |
| Placebo (n=154) | 9.9 (9.5) | −3.3 (5.9) | 10.5 (10.1) | −3.6 (6.2) | ||||
| Week 2 | ||||||||
| Methylnaltrexone 12 mg qd (n=130) | 12.7 (9.6) | −0.7 (8.5) | −0.6 (−2.3 to 1.1) | 0.52 | 13.8 (10.2) | −0.7 (9.0) | −0.5 (−2.3 to 1.3) | 0.61 |
| Methylnaltrexone 12 mg qod (n=130) | 12.5 (9.8) | −0.6 (8.7) | −0.6 (−2.3 to 1.1) | 0.49 | 13.6 (10.3) | −0.4 (9.2) | −0.3 (−2.1 to 1.5) | 0.71 |
| Placebo (n=151) | 13.2 (10.9) | −0.1 (7.2) | 14.0 (11.6) | −0.1 (7.8) | ||||
| Week 4 | ||||||||
| Methylnaltrexone 12 mg qd (n=121) | 11.4 (9.9) | −2.0 (8.4) | −1.9 (−3.8 to 0.0) | 0.05 | 12.2 (10.5) | −2.1 (9.0) | −2.0 (−3.9 to 0.0) | 0.06 |
| Methylnaltrexone 12 mg qod (n=117) | 12.2 (10.2) | −0.5 (9.8) | −0.6 (−2.5 to 1.3) | 0.52 | 13.3 (10.8) | −0.3 (10.5) | −0.4 (−2.4 to 1.7) | 0.72 |
| Placebo (n=142) | 13.4 (10.7) | −0.2 (7.4) | 14.2 (11.2) | −0.2 (7.9) | ||||
Notes:
a
The SOWS is a 16-item, patient-reported scoring system. Each item is scored from 0 (not at all) to 4 (extremely), with a total maximum score of 64: without abdominal-cramping-related items (maximum score, 60);
b
difference in adjusted change from baseline versus placebo;
c
approximately 1 hour after drug administration.
Abbreviations: CI, confidence interval; qd, once daily; qod, every other day; RCT, randomized controlled trial; SD, standard deviation; SOWS, subjective opiate withdrawal scale.