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. Author manuscript; available in PMC: 2016 Jun 1.
Published in final edited form as: Gastroenterology. 2015 Feb 13;148(7):1311–1319.e6. doi: 10.1053/j.gastro.2015.02.008

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)

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]

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]

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)

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

a

Data missing for one patient each in the 0·5 mg and 1·0 mg TID group

b

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