Trulance CIC Study Design

Weekly responder

Patient fulfills both ≥3 CSBMs* in a given week + an increase of ≥1 CSBM from baseline in the same week

Overall responder

Same patient must be a weekly responder for 9 out of the 12 treatment weeks

Efficacy responder
New criteria

Same patient must be a weekly responder for ≥3 of the last 4 treatment weeks (sustained)

STUDY details

*A complete spontaneous bowel movement (CSBM) is a spontaneous bowel movement (SBM) with the sense of complete evacuation.1

Primary endpoint: Efficacy responders over the 12-week treatment period vs placebo1,2

Trulance CIC efficacy: primary endpoint

Only Trulance met the most stringent primary endpoint criteria, evaluated in the largest Phase 3 CIC clinical trials to date1-4

STUDY details

*A complete spontaneous bowel movement (CSBM) is a spontaneous bowel movement (SBM) with the sense of complete evacuation.1

Significantly increased and maintained mean weekly SBMs over 12 weeks vs placebo (Study 1)1,2

Trulance CIC efficacy: frequency of spontaneous bowel movements

Similar results were observed in a second pivotal study2

Trulance provided a significantly greater percentage of patients with an SBM within 24 hours of the first dose2

  • ~60% with Trulance vs 40% with placebo (p<0.001) in Study 1
  • 44% with Trulance vs 36% with placebo (p=0.028) in Study 2
STUDY details

*An SBM is a bowel movement that occurs in the absence of laxative use within the previous 24 hours.1

A second pivotal Trulance study of similar design resulted in an overall 12-week average of 4.4 SBMs per week vs 3 SBMs with placebo.2

End of study drug administration.

Significantly improved mean stool consistency over 12 weeks vs placebo2

Trulance CIC efficacy: stool consistency

Stools that were easier to pass2

  • Trulance significantly reduced straining scores by 40% vs 26% with placebo (p<0.001)

Similar results were observed in a second pivotal study2*

STUDY details

*A second pivotal study of similar design resulted in significantly improved mean stool consistency throughout the 12-week treatment period (p<0.001).2

End of study drug administration.