Trulance

The efficacy of Trulance for the management of symptoms of IBS-C was established in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in adult patients (Study 3 and Study 4). In the Intention-to-Treat (ITT) population, patients in Study 3 (n=699) and in Study 4 (n=754) received treatment with placebo or Trulance 3 mg once daily. In clinical studies, study medication was administered without respect to food intake. 

The efficacy of Trulance was assessed using a responder analysis based on abdominal pain intensity and a stool frequency responder (CSBM) endpoint. Efficacy was assessed using information provided by patients on a daily basis through an electronic phone diary system. 

A responder was defined as a patient who met both the abdominal pain intensity and stool frequency responder criteria in the same week for at least 6 of the 12 treatment weeks. The abdominal pain intensity and stool frequency responder criteria assessed each week were defined as:  

• Abdominal pain intensity responder: a patient who experienced a decrease in the weekly average of worst abdominal pain in the past 24 hours score (measured daily) of at least 30% compared with baseline weekly average.  
• Stool frequency responder: a patient who experienced an increase of at least 1 CSBM per week from baseline. 

Results are shown below as follows:  

Study 3 

• Efficacy Responder Rates: 30% (Trulance) vs 18% (Placebo); treatment difference: 12% (95% CI, 6%-18%).
• Abdominal Pain Responder: 41% (Trulance) vs 32% (Placebo)
• CSBM Responder: 48% (Trulance) vs 35% (Placebo)

Study 4 

• Efficacy Responder Rates: 21% (Trulance) vs 14% (Placebo); treatment difference: 7% (95% CI, 2%-13%).
• Abdominal Pain Responder: 33% (Trulance) vs 23% (Placebo)
• CSBM Responder: 34% (Trulance) vs 28% (Placebo)

In both studies, the proportion of responders who were also weekly responders for at least 2 of the 4 treatment weeks in month 3, the last month of treatment was greater in the Trulance groups versus placebo. 

Over the 12-week treatment period, improvements were observed in both stool consistency (as measured by the BSFS) and in the amount of straining with bowel movements (amount of time pushing or physical effort to pass stool) in the Trulance group versus placebo. 

The efficacy of Trulance for the management of symptoms of CIC was evaluated in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in adult patients (Study 1 and Study 2). In the Intention-toTreat (ITT) population, patients in Study 1 (n=905) and in Study 2 (n=870) were randomly assigned 1:1 to either placebo or Trulance 3 mg, once daily. In clinical studies, study medication was administered without respect to food intake. 
 
The efficacy of Trulance was assessed using a responder analysis and change-from-baseline in complete spontaneous bowel movement (CSBM) and spontaneous bowel movement (SBM) endpoints. Efficacy was assessed using information provided by patients on a daily basis in an electronic diary. 

A responder (primary endpoint) was defined as a patient who had at least 3 CSBMs in a given week and an increase of at least 1 CSBM from baseline in the same week for at least 9 weeks out of the 12-week treatment period and at least 3 of the last 4 weeks of the study. 

Results are shown below as follows:

Study 1 

• Efficacy Responder Rates:  21% (Trulance) vs 10% (Placebo); treatment difference: 11% (95% CI, 6.1%-15.4%); P <0.005.

Study 2 

• Efficacy Responder Rates:  21% (Trulance) vs 13% (Placebo); treatment difference: 8% (95% CI, 2.6%-12.4%); P <0.005.

In both studies, improvements in the frequency of CSBMs/week were seen as early as week 1 with improvement maintained through week 12. The difference between the Trulance group and the placebo group in the mean change of CSBMs/week frequency from baseline to week 12 was approximately 1.1 CSBMs/week. 

Over the 12-week treatment period, improvements were observed in stool frequency (number of CSBMs/week and SBMs/week) and/or stool consistency (as measured by the Bristol Stool Form Scale [BSFS]), and/or in the amount of straining with bowel movements (amount of time pushing or physical effort to pass stool) in the Trulance group versus placebo.