Table 1.
Patient Demographics and Disease Characteristics
Larazotide Acetate (n=258) | |||||
---|---|---|---|---|---|
| |||||
Placebo (n=84) | 0·5 mg TID (n=86) | 1·0 mg TID (n=85) | 2·0 mg TID (n=87) | Total (N=342) | |
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General characteristics | |||||
Age (years), mean [SD] | 45·5 [14·6] | 44·2 [14·4] | 46·2 [15·0] | 44·7 [16·0] | 45·2 [15·0] |
Female, n (%) | 69 (82·1) | 73 (84·9) | 71 (83·5) | 72 (82·8) | 285 (83·3) |
White, n (%) | 83 (98·8) | 84 (97·7) | 85 (100) | 86 (98·9) | 338 (98·8) |
Weight (kg), mean [SD] | 74·3 [16·8] | 75·5 [16·0] | 72·2 [15·4] | 73·4 [15·3] | 73·9 [15·8] |
Height (cm), mean [SD] | 167·3 [9·6] | 165·4 [8·9] | 166·2 [8·6] | 167·4 [8·5] | 166·5 [8·9] |
Body Mass Index (kg/m2), mean [SD] | 26·6 [5·4] | 27·6 [5·3] | 26·0 [4·6] | 26·1 [4·6] | 26·6 [5·0] |
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Clinical characteristics | |||||
Time since CeD symptom onset (months), mean [SD] | 145·5 [141·1] | 149·2 [144·8]a | 162·9 [150·6]a | 174·6 [174·7] | 158·1 [158·3]a |
Time since CeD diagnosis* (months), mean [SD] | 60·3 [51·3] | 58·0 [50·1]b | 66·7 [68·2]b | 71·5 [65·07]b | 64·1 [59·2]b |
Time on most recent GFD* (months), mean [SD] | 62·1 [58·7] | 60·3 [60·1] | 71·4 [86·2] | 70·9 [63·7] | 66·2 [68·0] |
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Symptoms at diagnosis, n (%) | |||||
Diarrhea | 67 (79·8) | 68 (79·1) | 69 (81·2) | 64 (73·6) | 268 (78·4) |
Bloating | 75 (89·3) | 77 (89·5) | 78 (91·8) | 78 (89·7) | 308 (90·1) |
Abdominal distention/ Stomach swelling | 64 (76·2) | 62 (72·1) | 68 (80·0) | 68 (78·2) | 262 (76·6) |
Recurrent abdominal pain | 72 (85·7) | 78 (90·7) | 76 (89·4) | 75 (86·2) | 301 (88·0) |
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Scores at baseline, mean [SD] | |||||
CeD-GSRS | 3·26 [0·92] | 3·05 [0·84] | 3·21 [0·77] | 3·25 [0·96] | Not Calculated |
Total GSRS | 3·03 [0·82] | 2·89 [0·80] | 3·03 [0·75] | 3·09 [0·89] | |
CeD PRO Abdominal Domain | 2·56 [1·71] | 2·19 [1·34] | 2·63 [1·59] | 2·90 [1·58] | |
CeD PRO GI Domain | 2·27 [1·46] | 1·86 [1·10] | 2·23 [1·29] | 2·35 [1·29] | |
Average weekly number of bowel movements† | 9·00 [7·11] | 7·59 [4·62] | 7·25 [4·78] | 7·95 [5·45] |
Assessed at screening visit
As recorded in the Bristol Stool Form Scale (BSFS) daily diary
Data missing for one patient each in the 0·5 mg and 1·0 mg TID group
Data missing for one patient in each of the three larazotide acetate treatment groups
CeD = Celiac Disease; GFD = gluten-free diet; GSRS = Gastrointestinal Symptom Rating Scale; CeD-GSRS = Celiac Disease focused domains of the Gastrointestinal Symptom Rating Scale; CeD PRO = Celiac Disease Patient Reported Outcome; BSFS = Bristol Stool Form Scale
There were no significant differences between cohorts in any measure