TABLE 1. Subjects Randomization.
Table 1 N=90 |
Placebo N= 44 |
Drug N=46 |
p-value |
---|---|---|---|
Age (in years) | Mean (Std) =13.0(2.7) Median = 13.0 Range = 8 to 17 |
Mean (Std) =12.5(2.9) Median = 12.5 Range = 8 to 17 |
0.39 |
Gender: Female, (%) | 70 % | 76 % | 0.50 |
Functional Dyspepsia | 8 % | 13 % | 0.71 |
Functional Abdominal Pain | 31 % | 53 % | 0.07 |
IBS | 62 % | 40 % | 0.07 |
Compliance confirmed | 78 % | 70 % | 0.39 |
Consultations to Pediatrician | 89% | 93% | 0.48 |
Consultations to ER | 23% | 35% | 0.25 |
Onset of Symptoms (months prior to study enrollment) | 24 | 27 | 0.35 |
Baseline intensity of pain (0-100 mm) | Mean(Std) = 47.7 (14.2) Median = 45.3 Range = 24.3 to 75.3 |
Mean(Std) =48.9 (19.5) Median = 48.1 Range = 7.1 to 100.0 |
0.46 |