Table 3.
Efficacy of Oral Naldemedine in Patients with Chronic Non-Cancer Pain
| Trial | Ref | Phase and Study Design | No of Patients | Treatment | Primary Endpoint | Secondary Endpoints (Mean Change from Baseline to the Last 2 wks) |
||
|---|---|---|---|---|---|---|---|---|
| Proportion of Responders (% pts) # | SBMs/wk | CSBMs/wk | SBMs/wk Without Straining | |||||
| V9231 – COMPOSE 1 | Hale et al37 | Phase III. Multicentre, double-blind, randomised, parallel-group trial |
Nal 274 Placebo 273 |
Nal 0.2 mg OD for 12 wks | Nal 47.6% Placebo 34.6% (p=0.002) |
Nal +3.42 Placebo +2.12 (p<0.0001) |
Nal +2.58 Placebo +1.57 (p<0.0001) |
Nal +1.46 Placebo +0.73 (p<0.001) |
| V9232 – COMPOSE 2 | Hale et al37 | Phase III. Multicentre, double-blind, randomised, parallel-group trial | Nal 277 Placebo 276 | Nal 0.2 mg OD for 12 wks | Nal 52.5% Placebo 33.6% (p<0.0001) |
Nal +3,56 Placebo +2.16 (p<0.001) |
Nal +2.77 Placebo +1.62 (p<0.001) |
Nal +1.85 Placebo +1.10 (p<0.01) |
Notes: #Responders had at least three SBMs per week with an increase from baseline of at least one SBM per week for at least 9 weeks of the 12-week treatment period and at least 3 of the last 4 weeks of the 12-week treatment period (baseline: the average number of SBMs/week during the 2 weeks before random assignment).
Abbreviations: wk, week; Nal, naldemedine; SBMs, spontaneous bowel movements; CSBMs, SBMs with a feeling of complete evacuation.