Table 1. Summary of patient demographics and baseline characteristics (ITT population).
| Placebo (N=401) | Linaclotide 72 μg (N=411) | Linaclotide 145 μg (N=411) | |
|---|---|---|---|
| Demographic data | |||
| Age (years), mean (range) | 45.2 (14.7) | 45.8 (14.3) | 46.8 (14.0) |
| ≥65 years, n (%) | 39 (9.7) | 36 (8.8) | 43 (10.5) |
| Sex, n (%) | |||
| Female | 316 (78.8) | 312 (75.9) | 314 (76.4) |
| Male | 85 (21.2) | 99 (24.1) | 97 (23.6) |
| Race, n (%) | |||
| White | 276 (68.8) | 298 (72.5) | 294 (71.5) |
| Black | 102 (25.4) | 93 (22.6) | 94 (22.9) |
| Other | 23 (5.7) | 20 (4.9) | 23 (5.6) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 175 (43.6) | 178 (43.3) | 175 (42.6) |
| Not Hispanic or Latino | 226 (56.4) | 233 (56.7) | 236 (57.4) |
| BMI, mean (s.d.) | 29.3 (6.5) | 28.9 (6.0) | 29.3 (6.2) |
| SBM Stratum, n (%) | |||
| ≤1 SBM/week | 175 (43.6) | 167 (40.6) | 176 (42.8) |
| >1 SBM/week | 226 (56.4) | 244 (59.4) | 235 (57.2) |
| Baseline data, mean (s.d.) | |||
| CSBMs/week | 0.3 (0.5) | 0.2 (0.5) | 0.2 (0.4) |
| SBMs/week | 1.6 (1.2) | 1.7 (1.4) | 1.7 (1.4) |
| Stool consistencya | 2.0 (1.0) | 1.9 (0.9) | 2.0 (0.9) |
| Strainingb | 3.5 (0.9) | 3.6 (0.9) | 3.5 (0.8) |
| Constipation severityc | 3.7 (0.8) | 3.7 (0.8) | 3.6 (0.8) |
| Abdominal bloatingd | 5.3 (2.4) | 5.2 (2.6) | 5.3 (2.6) |
| Abdominal discomfortd | 4.8 (2.6) | 4.6 (2.7) | 4.7 (2.7) |
| Abdominal paind | 4.1 (2.8) | 4.1 (2.9) | 4.2 (2.9) |
| Stool softener/bulk laxative use, n (%)e | |||
| Bulk-forming laxatives | 1 (0.2) | 5 (1.2) | 3 (0.7) |
| Softeners, emollients | 2 (0.5) | 7 (1.7) | 5 (1.2) |
BMI, body mass index; CSBM, complete spontaneous bowel movement; SBM, spontaneous bowel movement.
Assessed using the BSFS: 1=separate hard lumps, like nuts (hard to pass); 2=sausage-shaped, but lumpy; 3=like a sausage but with cracks on its surface; 4=like a sausage or snake, smooth and soft; 5=soft blobs with clear cut edges (passed easily); 6=fluffy pieces with ragged edges, a mushy stool; 7=watery, no solid pieces (entirely liquid).
Assessed using a five-point ordinal scale: 1=not at all, 2=a little bit, 3=a moderate amount, 4=a great deal, 5=an extreme amount.
Assessed using a five-point ordinal scale: 1= none; 2=mild; 3=moderate; 4=severe; 5=very severe.
Assessed using a 11-point NRS: 0=none; 10=severe.
Use of fiber, bulk laxatives, or stool softeners was acceptable during the trial if the patient had been on a stable dose during the 30 days before the screening visit and planned to continue on a stable dose throughout the trial.