Table 1.
Study/phase/design | Number of patients/sex/duration/doses studied | Primary endpoints | Efficacy results | Secondary endpoints | Efficacy results |
---|---|---|---|---|---|
Andresen et al. [2007] | N = 36 | Gastric transit | No treatment effect | NA | NA |
Phase IIa | Female patients = 100% | Small bowel transit | Increased ascending colon emptying t½ times (p = 0.015) and increased total colonic transit times at 48 h (p = 0.02) (for 1000 µg dose; p = 0.004) | ||
Randomized, double-blind, placebo-controlled trial | 5-day baseline and 5-day treatment periods | Colonic transit (by scintigraphy) | Increased stool frequency, decreased stool consistency, improved ease of passage, and time to first bowel movement (p < 0.001) | ||
Placebo, 100 and 1000 µg linaclotide | Bowel function (using stool diaries) | ||||
Johnston et al. [2010] | N = 420 | Change in the number of CSBMs | For the 75, 150, 300, 600 µg linaclotide doses: mean change in CSBMs/week were 2.90, 2.49, 3.61 and 2.68 respectively (p < 0.01) | Effect on individual symptoms | Improved frequency of SBMs (p ≤ 0.001), CSBMs (p ≤ 0.01), severity of straining (p ≤ 0.001), stool consistency (p ≤ 0.001), and abdominal pain scores (p ≤ 0.05) |
Phase IIb | Female patients = 92% | Proportion of patients who were CSBM responders was 25%, 19.5%, 32% and 24% respectively (all significant except for the 150 µg dose) | Proportion of CSBM responders Proportion of Global relief responders | Higher proportion of adequate relief responders | |
Randomized, double-blind, parallel-group, multicenter, placebo-controlled trial | 12-week treatment period | Quality of life | Higher proportion of global relief responders | ||
Placebo, 75, 150, 300 and 600 µg linaclotide | IBS-QOL scores increased ≥14 points in all linaclotide treatment groups |
CSBM, complete spontaneous bowel movement; IBS, irritable bowel syndrome; NA, not applicable; QOL, quality of life; SBM, spontaneous bowel movement.