Table 1.
Baseline Characteristics by Treatment Groups (N = 68). Values are Medians, Interquartile Ranges and Absolute Ranges. All Subjects were Prepubertal at Baseline. Significance for Between-Group Differences were Tested by One-Way Anova
| Number Evaluable | Age (years) | Bone Age (years) | HT-SDS | Height Velocity cm/yr | Maximal GH in 2 stimulation tests (ng/mL) | Peak GH to single-dose LUM-201 (ng/mL) | IGF-I (ng/mL) | |
|---|---|---|---|---|---|---|---|---|
| All subjects | 68 | 9.2 (7.2,10.8) (3.7, 14.3) |
8.5 (5.9, 10.4) (1.8, 10.5) |
−3.3 (−4.5, −2.5) (−7.0,−1.7) |
4.4 (3.5, 5.1) (0.1, 7.6) |
5.4 (1.8, 7.6) (0.8, 10) |
15 (3.5, 49) (1.9, 103) |
51 (24 111) (10, 231) |
| Placebo | 22 | 8.5 (5.9, 10.4) (3.7, 14) |
5.5 (4.0, 7.8) (1.8, 10) |
−3.4 (−4.1, −2.5) (−7.0, −1.7) |
4.4 (3.5, 5.1) (1.1, 7.6) |
6.4 (3.0, 8.4) (1.2, 10) |
26 (5.5, 56) (2.2, 103) |
56.5 (23 113) (10, 180) |
| LUM-201 0.4 mg/kg/d | 22 | 10.6 (9.0, 12.0) (5.3, 14.3) |
6.7 (4.5, 7.8) (2.3, 10) |
−3.8 (−5.3,−2.9) (−6.9, −1.8) |
3.6 (2.7,4.5) (0.1, 5.9) |
3.4 (1.7, 7.3) (0.8, 8.9) |
9.4 (2.9, 39) (1.9, 81) |
48.5 (23, 96) (13, 231) |
| LUM-201 0.8 mg/kg/d | 24 | 8.3 (7.1, 10.1) (5.1, 12.4) |
6.5 (5.0, 8.0) (2.7, 10.5) |
−2.8 (−3.7,−2.3) (−6.0, −1.8) |
3.8 (3.5,4.5) (1.1, 5.4) |
5.9 (1.6,7.5) (1.1, 9.4) |
13 (3.9, 52) (1.9, 102) |
50 (29 122) (15, 281) |
| P value for between-group differences | 68 | 0.025 | 0.35 | 0.08 | 0.11 | 0.2 | 0.48 | 0.94 |
| Placebo switch to daily rhGH | 20 | 9.0 (6.6, 10.8) (4.1, 14.5) |
5.9 (4.2, 8.0) (2.0, 10.5) |
−3.5 (−4.2,−2.7) (−6.7, −1.6) |
4.6 (3.4,5.6) (0.1, 6.8) |
6.3 (3.0, 7.8) (1.2, 10) |
21 (4.6, 43) (2.2, 103) |
73 (24, 118) (10, 139) |
Abbreviations: ANOVA, analysis of variance; GH, growth hormone; HT-SDS, height standard deviation score; IGF-I, insulin-like growth factor I.