Clinical Trial Search

Primary: Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment — 1.40; 2.58 Number of SBMs/week

Primary: Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment — 1.96; 3.42; 1.44 Number of SBMs/week

Primary: Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week) — 1.474; 2.799; 3.382 Number of SBMs per week — p=0.0035

Primary: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response — 47.6; 34.6 percentage of participants — p=0.0020

Primary: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response — 52.5; 33.6 percentage of participants — p=<0.0001

Primary: Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose — 34.2; 9.9 percentage of participants — p=<0.001

Primary: Incidence of Patients Experiencing at Least One Adverse Event (AE) — 437; 195 Participants

Primary: Number of Participants Classified as Treatment Responders Within 12 Weeks — 59; 41 Participants

Primary: Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1 — 1.8; 2.6; 1.9; 3.6 Number of SBMs/week — p=0.7781

Primary: Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8 — 2.4; 2.6 Spontaneous Bowel…

Primary: Mean Weekly Spontaneous Bowel Movements at Week 8 — 2.4; 3.2 SBMs/Week

Primary: Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4 — 21.05; 24.64; 27.40; 18.18…

Primary: Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month — 1.4; 4.9; 4.9; 5.0 Weekly SBMs

Primary: Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12 — 81; 92; 68 Number of patients — p=0.202

Primary: Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12 — 87; 95; 63 Number of patients — p=0.015

Primary: Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing. — 8; 5; 4; 6 participants

Primary: Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week — 1.42; 1.98; 3.37; 3.64 spontaneous bowel movements…

Primary: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone — 33 percentage of participants

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

Primary: Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment — 124; 118; 4 Participants

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

Primary: Number of Participants With Response — 19; 4 participants

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

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

Primary: Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym) — -0.22; -0.29 units on a scale — p=<0.05

Primary: Occurrence of Bowl Movement — 2; 2; 5 Participants

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

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

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

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