Table 5

Baseline characteristics of randomised controlled studies

FormulationsDesignNEpisodesGender (% female)Age (years)RaceCancer typePain typeOpioid useReference
OTFC
nasal spray
Open, co862×6 per patient4355Cau: 100%No dataNo dataNo data59
FPNSnasal spray
Open, co6297 pectin
91 nasal
4663No data (Italy)Lung: 21%
Urogenital: 17%
GI: 15%
No dataMor: 192 mg60
SLF
Placebo
DB, co6610 per patient (7 SLF, 3 placebo)5462White: 84%
Black: 5%
Asian: 2%
No dataNo dataMor: 60–1000 mg
TDF: 50–300 µg/hour
61
SLF
Placebo
DB, co379 per patient (6 SLF, 3 placebo)4166Asian: 100%Lung: 26%
Breast: 7%
Gastric: 7%
No dataMor: 345 mg
Oxycodone: 29 mg
TDF: 48 µg/hour
62
SLF
IRMS oral
SB4030 days4365SpainProstate: 25%
Lung: 15%
Breast: 15%
No dataMor: 60–1000 mg
TDF: 50–300 µg/hour
63
SLF-E
Placebo
DB, co789 per patient (6 OTFC, 3 placebo)4465CzechiaUrogenital: 34%
Digestive: 27%
Head/neck: 15%
No dataFentanyl: 74% (no dose)64
OTFC
IRMS oral
DB, DD, co932×5 per patient4755White: 92%
Black: 7%
Hisp: 1%
Breast: 16%
Lung: 17%
Colon: 15%
Prostate: 8%
Noc: 80%
Neu: 19%
Mor: 60–1000 mg (n=61)
TDF: 50–300 µg/hour (n=28)
65
OTFC
Morphine IV
Open, co25535259ItalySom: 36%
S/V: 12%
S/N: 12%
Vis: 8%
V/N: 8%
Neu: 16%
Mor: 120 mg66
OTFC
Placebo
DB, co9210 per patient (7 OTFC, 3 placebo)
804 in total
5554White: 93%
Black: 5%
Asian: 1%
Breast: 23%
Lung: 18%
Colon: 13%
Uterine: 8%
Haematol: 13%
Som: 52%
Vis: 32%
Neu: 14%
Mor: 30–600 (n=63)
TDF: 50–225 µg/hour (n=21)
67
Buccal
Placebo
DB, co7710 per patient (7 buccal, 3 placebo)
493 in total
4558White: 88%
Black: 1%
Other: 10%
No dataNoc: 47%
Neu: 21%
Mixed: 32%
Mor: 213 mg (equivalent)68
Buccal
Placebo
DB, co8710 per patient (7 buccal, 3 placebo)
716 in total
6254White: 79%
Black: 8%
Other: 13%
No dataNoc: 41%
Neu: 17%
Mixed: 42%
Mor: 279 mg (equivalent)69
Buccal
Placebo
DB, co739 per patient (buccal, 3 placebo)3661JapaneseNo dataNoc: 60%
Neu: 6%
Mixed: 35%
Mor: 112 mg (equivalent)70
Buccal film
Placebo
DB, co829 per patient (6 buccal film, 3 placebo)
571 in total
55White: 90%
Black: 8%
Other: 3%
Breast: 23%
Lung: 17%
Colon: 11%
Gastric: 7%
Pancreatic: 6%
Neu: 32%71
Nasal spray
Placebo
DB, co1118 per patient (6 nasal spray, 2 placebo)5061White: 96%Breast: 16%
Lung: 15%
Colon: 13%
Female gen: 11%
Prostate: 10%
Urologic: 10%
No dataMorphine: 91%72
FPNS
IRMS oral
DB, DD, co11410 per patient (5 FPNS, 5 placebo)
740 in total
4656Cau: 49%
Black: 1%
Indian: 53%
No dataNo dataMorphine: 201 mg73
FPNS
IRMS oral
Open534 per patient5863Lung: 28%
Urogenital: 26%
Breast: 19%
No dataNot stated: 60–120 mg in 80% of patients74
FPNS
Placebo
DB, co8410 per patient (7 FPNS, 3 placebo)
659 in total
4754Cau: 68%
Black: 12%
Other: 21%
Breast: 17%
Lung: 13%
Retic: 12%
Bowel: 12%
Prostate: 7%
No dataMorphine: 254 mg75
  • Cau, Caucasian; co, crossover; DB, double-blind; DD, double-dummy; FPNS, fentanyl pectin nasal spray; GI, gastrointestinal; Hisp, Hispanic; IRMS, immediate release morphine sulfate; IV, intravenous; Mor, morphine; Nasal, fentanyl nasal spray; NEu, neuropathic; Noc, nociceptive; OTFC oral transmucosal fentanyl citrate; SB, single blind; SLF, sublingual fentanyl (Abstral); SLF-E, sublingual fentanyl ethypharm (Recivit); S/N, somatic-neuropathic; Som, somatic; S/V, somatic-visceral; TDF, transdermal fentanyl; V/N, visceral-neuropathic; Vis, visceral.