| Dose |
Bowel movements |
Author |
| Naldemedine 0.2 mg vs placebo once daily |
Did not assess bowel movements |
Wild et al. [50] |
| Naldemedine 0.1 mg, 0.2 mg, 0.4 mg once daily vs placebo |
Change in spontaneous bowel movements frequency (primary endpoint) was higher with all naldemedine doses versus placebo (p<0.05 for all comparisons), as were spontaneous bowel movements responder rates and change in complete spontaneous bowel movements frequency. Change in spontaneous bowel movements frequency without straining was significantly improved with naldemedine 0.2 and 0.4 (but not 0.1) mg versus placebo (at least p<0.05) |
Katakami et al. [51] |
| Naldemedine 0.2 mg once daily vs placebo |
The proportion of spontaneous bowel movements responders was significantly greater with naldemedine than with placebo (71.1% vs 34.4). A greater change from baseline was observed with naldemedine than with placebo in the frequency of spontaneous bowel movements/week (5.16 vs 1.54; p<0.0001), spontaneous bowel movements with complete bowel evacuation/week (2.76 vs 0.71; p<0.0001), and spontaneous bowel movements without straining/week. |
Katakami et al. [52] |
| Naldemedine 0.2 mg vs placebo |
Not the primary endpoint. Greater increases were observed in the mean frequency of spontaneous bowel movements per week in the naldemedine group than in the placebo group. |
Hale et al. [53] |
| Naldemedine 0.1 mg, 0.2 mg, or 0.4 mg once daily vs placebo |
Weekly spontaneous bowel movements frequency was significantly higher with naldemedine 0.2 mg (3.37, p = 0.0014) and 0.4 mg (3.64, p = 0.0003), but not with 0.1 mg (1.98, p = 0.3504), vs placebo (1.42). |
Webster et al. [54] |
| Naldemedine 0.2 mg once daily vs placebo |
There was a significant and sustained increase from baseline in the frequency of bowel movements with naldemedine vs placebo throughout the 52-week treatment period. |
Webster et al. [55] |
| Naldemedine 0.2 mg once daily |
Did not assess bowel movements |
Saito et al. [56] |
