Trulance was evaluated in the largest Phase 3 CIC clinical trials to date, involving more than 2600 patients1-4

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

Only Trulance met the most stringent 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 placebo1,2

Patients experienced a significant increase in mean SBMs at Week 12 (p<0.001)1,2

  • From 1.9 SBMs at baseline to 5.3 with Trulance
  • From 2.2 SBMs at baseline to 3.6 with placebo

Trulance provided a significantly greater percentage of patients with a SBM within 24 hours of the first dose1,2

  • 60% with Trulance vs 40% with placebo (p<0.001) in Study 1

Similar results were replicated in a second pivotal study

  • 44% with Trulance vs 36% with placebo (p<0.001) in Study 2
STUDY details

*A SBM is a bowel movement that occurs in the absence of laxative use within the previous 24 hours.2

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

Significantly improved mean stool consistency over 12 weeks vs placebo

Stools that were easier to pass

  • Trulance significantly reduced straining scores by ~40% (p<0.001)2

Similar results were replicated 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