Table 1

Subject disposition, demographics and baseline clinical characteristics in pooled phase II/III clinical trial program

Intravenous meloxicam
Placebo
n=517
5–15 mg
n=327
30 mg
n=910
60 mg
n=189
Overall
N=1426
Completed study, n (%)504 (97.5)324 (99.1)886 (97.4)189 (100.0)1399 (98.1)
Reason for discontinuation, n (%)
 Lack of efficacy002 (0.2)02 (0.1)
 Adverse event1 (0.2)1 (0.3)001 (0.1)
 Withdrawal by subject4 (0.8)1 (0.3)11 (1.2)012 (0.8)
 Lost to follow-up8 (1.5)010 (1.1)010 (0.7)
 Non-compliance01 (0.3)001 (0.1)
 Other001 (0.1)01 (0.1)
Mean (SD) age, years46.7 (13.84)43.0 (11.76)48.0 (14.59)40.1 (14.50)45.8 (14.29)
Gender, % male/female22.2/77.88.0/92.030.2/69.89.5/90.522.4/77.6
Race, n (%)
 White401 (77.6)325 (99.4)737 (81.0)173 (91.5)1235 (86.6)
 Black/African-American94 (18.2)0148 (16.3)10 (5.3)158 (11.1)
 Asian9 (1.7)1 (0.3)13 (1.4)1 (0.5)15 (1.1)
 American Indian/Alaska Native1 (0.2)01 (0.1)01 (0.1)
 Native Hawaiian/other Pacific Islander3 (0.6)04 (0.4)2 (1.1)6 (0.4)
 Other6 (1.2)1 (0.3)6 (0.7)2 (1.1)9 (0.6)
 Multiple3 (0.6)01 (0.1)1 (0.5)2 (0.1)
Mean (SD) body mass index, kg/m2 27.9 (4.33)25.6 (3.19)28.4 (4.81)26.4 (3.42)27.6 (4.53)
 Positive history for, n (%)
 Hypertension107 (20.7)14 (4.3)232 (25.5)9 (4.8)255 (17.9)
 Diabetes21 (4.1)2 (0.6)49 (5.4)1 (0.5)52 (3.6)
 Gastrointestinal conditions*66 (12.8)4 (1.2)153 (16.8)4 (2.1)161 (11.3)
 Aged >65 years with impaired renal function, n (%)†35 (6.8)095 (10.4)1 (0.5)96 (6.7)
  • *Prior or concomitant gastrointestinal esophageal reflux disease, ulcer and/or bleeding.

  • †Impaired renal function defined as a glomerular filtration rate of 60‒89 mL/min/1.73 m2.

  • SD, standard deviation.