Trulance IBS-C Study Design

Weekly responder
(Abdominal Pain Intensity + Stool Frequency)

Abdominal Pain Intensity:
≥30% decrease in
Worst Abdominal Pain Intensity score vs baseline weekly average

Stool Frequency:
≥1 increase in CSBM* vs baseline weekly average

Overall responder
Primary endpoint

Meets both weekly responder criteria in the same week for ≥6 of the 12 treatment weeks

Sustained responder
Key secondary endpoint

Overall responder + weekly responder for ≥2 of the last 4 weeks of treatment

STUDY details

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

Percentage of overall efficacy responders (abdominal pain and CSBMs*) to Trulance was significantly greater vs placebo1

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

Trulance IBS-C efficacy: primary endpoint

Key secondary endpoint—sustained efficacy responder: Overall responder plus a weekly responder for ≥2 of the last 4 treatment weeks2

  • 28% vs 17% for placebo in Study 3 (p<0.05)
  • 21% vs 14% for placebo in Study 4 (p<0.05)

Provided well-formed bowel movements

  • Significantly improved stool consistency throughout the 12-week treatment period vs placebo (p<0.001)1,2
STUDY details

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

Significantly reduced abdominal pain throughout the 12-week treatment period in a pooled analysis of the secondary endpoint2*

Trulance IBS-C efficacy: abdominal pain reduction

*Abdominal pain was assessed on a rating scale of 0 (none) to 10 (worst possible).2

End of study drug administration.

Significantly greater percentage of abdominal pain responders for ≥6 of 12 treatment weeks in a pooled analysis of the secondary endpoint2

Trulance IBS-C efficacy: abdominal pain responders STUDY details