Clinical Trial Search

Primary: Change From Baseline in Colonic Transit Time (CTT) — -727; -15; 366 minutes

Primary: Complete Spontaneous Bowel Movement (CSBM) Overall Responder — 46; 42; 7 participants — p=<0.0001

Primary: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 241; 14 Patients

Primary: Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. — 260; 133; 229; 161 mg/hour

Primary: % of Subjects With Treatment Emergent Adverse Events — 108 Participants

Primary: Spontaneous Bowel Movement (SBM) Frequency at Week 1 — 3.1; 4.4 SBMs/week — p=0.007

Primary: Severity of Constipation Symptoms — 0.96; 0.97; 0.63; 0.67 score on a scale

Primary: Complete Spontaneous Bowel Movement (CSBM) Overall Responder — 13; 34; 43; 202 participants — p=0.0012

Primary: Spontaneous Bowel Movement (SBM) Frequency at Week 1 — 3.6; 5.0 SBMs/week — p=0.003

Primary: The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period — 20.7; 25.1 percentage of…

Primary: Overall Responder 9/12 Weeks — 18.6; 16.8; 19.0; 10.7 % of Overall Responder 9/12 weeks

Primary: Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration — 6.7; 5.2 number of SBM per week — p=0.020

Primary: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) — 65; 389; 454 Participants

Primary: Treatment Recovery — 33; 19 participants — p=0.024

Primary: Responder for Complete Spontaneous Bowel Movement (CSBM) — 10; 14; 17; 22 participants — p=<0.05

Primary: Whole Gut Transit Time

Primary: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) — 399; 748 Participants

Primary: Frequency of Defecation. — 3.9; 5.1 days/week — p=<0.05

Primary: Responder of Complete Spontaneous Bowel Movement (CSBM) — 26; 5; 34; 55 participants — p=<0.05

Primary: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency — 2.59; 3.25; 3.57; 4.29 SBMs per week — p=0.0337

Primary: Change in Methane Production — 10645; 14635 parts per million*minutes

Primary: 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder — 13; 24; 158; 129 participants — p=0.0264

Primary: Percentage of 12-Week CSBM Overall Responders — 4.7; 13.4; 95.3; 86.6 percentage of participants — p=< 0.0001

Primary: The Number of High-Amplitude Propagating Contractions (HAPC) — 8.7; 2.9 Number of HAPC with amplitude ≥100mmHg — p=0.012

Primary: Change From Baseline in Frequency of Spontaneous Bowel Movements — 2.5; 4.0; 5.4; 1.7 Number of SBMs — p=<0.2

Primary: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) — 123; 620 Participants

Primary: Number of Participants With Adverse Events — 3; 6; 2; 6 Participants

Primary: Adverse Events — 0 Participants

Primary: Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month — 2.66; 2.75; 2.70; 2.75 Weekly SBMs

Primary: Change in Colonic Transit Time From Baseline to Day 15 — -1.7; 4.0; 2.5; 2.6 Hours