Table 4.

Change from baseline in OOWS, with and without abdominal-cramping-related items during the RCT double-blind phase

Treatment (n)	OOWS scorea
	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=148)	0.4 (1.1)	0.1 (0.6)	0.1 (−0.1 to 0.3)	0.3	0.5 (1.2)	0.2 (0.7)	0.1 (−0.1 to 0.4)	0.2
Methylnaltrexone 12 mg qod (n=145)	0.6 (1.6)	0.3 (1.3)	0.3 (0.1 to 0.5)	<0.001	0.7 (1.8)	0.4 (1.5)	0.4 (0.2 to 0.6)	<0.001
Placebo (n=161)	0.2 (0.8)	0.0 (0.4)			0.2 (0.9)	0.0 (0.5)
Week 2
Methylnaltrexone 12 mg qd (n=135)	0.4 (1.1)	0.1 (0.4)	0.1 (−0.1 to 0.2)	0.3	0.4 (1.2)	0.1 (0.5)	0.1 (−0.1 to 0.2)	0.3
Methylnaltrexone 12 mg qod (n=132)	0.3 (1.0)	0.0 (0.6)	0.0 (−0.1 to 0.1)	0.8	0.3 (1.0)	0.0 (0.7)	0.0 (−0.1 to 0.1)	0.9
Placebo (n=152)	0.2 (0.7)	0.0 (0.6)			0.2 (0.7)	0.0 (0.6)
Week 4
Methylnaltrexone 12 mg qd (n=124)	0.3 (1.1)	0.0 (0.7)	0.0 (−0.1 to 0.2)	0.5	0.3 (1.1)	0.0 (0.7)	0.1 (−0.1 to 0.20)	0.4
Methylnaltrexone 12 mg qod (n=120)	0.3 (1.1)	0.0 (0.6)	0.1 (−0.1 to 0.2)	0.5	0.3 (1.1)	0.0 (0.6)	0.1 (−0.1 to 0.2)	0.4
Placebo (n=143)	0.2 (0.6)	0.0 (0.6)			0.2 (0.6)	0.0 (0.6)

Notes:

^aThe OOWS consists of 13 items; each item that is considered to be present according to the observer receives 1 point. Higher scores indicate more severe withdrawal (maximum score, 13), without abdominal-cramping-related items (maximum score, 12);

^bdifference in adjusted change from baseline versus placebo;

^capproximately 1 hour after drug administration.

Abbreviations: CI, confidence interval; OOWS, objective opioid withdrawal scale; qd, once daily; qod, every other day; RCT, randomized controlled trial; SD, standard deviation.