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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 2.

Efficacy Endpoints in the MITT Population

Placebo (n=84) 0·5 mg TID (n=86) 1·0 mg TID (n=85) 2·0 mg TID (n=87)
PRIMARY ENDPOINT
 Average on-treatment CeD-GSRS score, mean [SD] 2·88 [0·72] 2·59 [0·7] 2·84 [0· 8] 2·92 [0·8]
  P value vs. placebo - ANCOVA, MMRM - p=0·022, p=0·005 NS, NS NS, NS
SECONDARY ENDPOINTS
 CeD-GSRS score change from baseline to end of treatment, mean [SD] −0·50 [1·0] −0·54 [0·9] −0·40 [1·0] −0·37 [1·0]
  P value vs. placebo - ANCOVA, MMRM NS, p=0·041 NS, NS NS, NS
 Average on-treatment score - CeD PRO Abdominal Domain, mean [SD] 2·27 [1·3] 2·04 [1·3] 2·59 [1·6] 2·77 [1·5]
  P value vs. placebo - ANCOVA, MMRM NS, NS NS, p=0·036 NS, NS
 Average on-treatment score – CeD PRO GI Domain, mean [SD] 2·05 [1·19] 1·69 [1·01] 2·21 [1·33] 2·31 [1·26]
 P value vs. placebo - ANCOVA, MMRM NS, NS NS, NS NS, NS
 Change from baseline to end treatment - CeD PRO Abdominal Domain, mean [SD] −0·43 [1·73] −0·26 [1·47] −0·18 [1·27] −0·16 [1·32]
 P value vs. placebo - ANCOVA, MMRM NS, NS NS, NS 0·023, NS
 Change from baseline to end treatment - CeD PRO GI Domain, mean [SD] −0·38 [1·45] −0·28 [1·24] −0·13 [1·00] 0·00 [1·23]
 P value vs. placebo - ANCOVA, MMRM NS, NS NS, NS 0·013, 0·028
EXPLORATORY ENDPOINTS
 Average on-treatment total GSRS score, mean [SD] 2·70 [0· 7] 2·47 [0·7] 2·70 [0·8] 2·76 [0·8]
  P value vs. placebo - ANCOVA, MMRM p=0·017, p=0·004 NS, NS NS, NS
 Average on-treatment scores of individual GSRS Domains, mean [SD]
  ANCOVA p value vs. placebo
   Diarrhea 2·77 [1·2] 2·40 [1·1], NS 2·61 [1·1], NS 2·74 [1·21], NS
   Indigestion 3·18 [0·8] 2·87 [0·8] p=0·029 3·18 [1·0], NS 3·23 [0·88], NS
   Constipation 2·58 [1·1] 2·45 [1·0], p=0·050 2·64 [1·1], NS 2·61 [1·14], NS
   Abdominal pain 2·58 [0·9] 2·42 [0·8], p=0·024 2·62 [0·8], NS 2·68 [0·94], NS
   Reflux 2·00 [1·1]
-		 1·87 [0·9], NS 2·08 [1·1], NS 2·19 [1·07], NS
 ≥50% reduction from baseline in weekly average score for ≥6 weeks, n (%), CMH p value vs. placebo
   CeD-GSRS 1 (1·2) 6 (7·2), NS 1 (1·2), NS 1 (1·2), NS
   CeD PRO Abdominal Domain 12 (14·3) 24 (28·6), p=0·022 12 (14·3), NS 17 (19·5), NS
   CeD PRO GI Domain 14 (16·7) 29 (34·5) p=0·002 15 (17·9), NS 15 (17·2), NS
 Average weekly number of bowel movements (BSFS)‡, mean [SD] 8·96 [7·0] 6·90 [4·2] 7·20 [4·2] 8·72 [5·9]
  ANCOVA p value vs. placebo* NS NS NS
 Average on-treatment weekly number of CeD PRO Symptomatic Days 2·38 [2·01] 1·73 [1·7] 2·48 [2·0] 2·63 [1·8]
  ANCOVA p value vs. placebo p=0·017 NS NS
 Average on-treatment weekly number of CeD PRO Improved Symptom Days 1·99 [2·0] 2·51 [1·9] 1·80 [1·9] 1·46 [1·6]
  ANCOVA p value vs. placebo p=0·034 NS NS
 Average on-treatment CeD PRO Non-GI Domain score, mean [SD] 2·75 [1·55] 2·44 [1·4] 2·73 [1·4] 3·11 [1·8]
  ANCOVA, MMRM p value vs. placebo - NS, p=0·010 NS, NS NS, NS
*

As recorded in the Bristol Stool Form Scale (BSFS) daily diary

CeD-GSRS = Celiac Disease focused domains of the Gastrointestinal Symptom Rating Scale; CeD PRO = Celiac Disease Patient Reported Outcome; ANCOVA = Analysis of covariance; MMRM = Mixed Model for Repeated Measures; CMH = Cochrane-Mantel-Haenszel; NS = not statistically significant (p>0·05)

All statistical analyses include baseline score, gender, baseline GSRS Stratum, and randomization cohort as covariates.