Phase 2 N=15 Use of Pancreatic Enzymes in Short Bowel Syndrome
Short Bowel Syndrome
Primary: Change in Coefficient of Fat Absorption — 2.3 percentage of fat absorbed
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=8 Short Bowel Syndrome and Teduglutide Versus Placebo
Short Bowel Syndrome
Primary: Gastric Emptying Half-Time (T1/2) — 113; 106 minutes — p=0.74
Phase 3 N=59 Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
Short Bowel Syndrome
Primary: Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24…
Phase 3 N=86 Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
Short Bowel Syndrome
Primary: Responder — 27; 13 subjects — p=0.002
Phase 3 N=84 Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
Short Bowel Syndrome
Primary: A Graded Response Score in Parenteral Nutrition (PN) Reduction — 15; 19; 24; 0 participants — p=0.007
Phase 2 N=9 Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
Short Bowel Syndrome
Primary: Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) — 9; 5; 3; 1 Participants
Phase 3 N=61 Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
Short Bowel Syndrome
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 6; 3; 1; 50 Participants
Phase 3 N=10 The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
Short Bowel Syndrome
Primary: Change in Absorption of Wet Weight/Fluids — 841.6; 1240.0 g/day — p== 0.0585
Phase 3 N=7 Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
Short Bowel Syndrome
Primary: Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) — -2.92 Liter per week (L/Week)
Phase 3 N=65 Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
Short Bowel Syndrome
Primary: Number of Subjects Achieving a 20% Reduction at Week 28 — 5; 3; 17; 14 Participants
Phase 3 N=88 Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
Short Bowel Syndrome
Primary: Percent Change in PN/IV Volume by Visit — -5.35; -6.44; -40.65; -12.88 percent change
Phase 3 N=106 Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
Short Bowel Syndrome
Primary: Change in Weekly Parenteral Support (PS) Volume — -5.13; -3.76; -2.85 L/week — p=0.0039
Phase 3 N=9 A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
Short Bowel Syndrome
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 7; 2 Participants
N/A N=4,561 Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario
Irritable Bowel Syndrome
Primary: Number of Participants With Post Infectious Irritable Bowel Syndrome — 23; 114 participants
Phase 3 N=42 A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
Short Bowel Syndrome
Primary: Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12 — 7.38; -9.95; -37.34; -39.11 percent change
Phase 3 N=10 Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
Short Bowel Syndrome
Primary: Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early…
N/A N=103 Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
HIV-associated Enteropathy
Primary: Frequency of Daily Unformed Bowel Movements — -2.46; -2.16; -2.20 abnormal or unformed stools
Phase 3 N=11 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
Short Bowel Syndrome
Primary: Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 — -4.92 Liter per week (L/week)
Phase 3 N=10 Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
Short Bowel Syndrome
Primary: Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data — -11.8; -26.2 mL/kg/day
Phase 3 N=29 Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
Short Bowel Syndrome
Primary: Number of Participants With Adverse Events (AEs) in Retrospective Observation Period — 23; 4; 23; 4 Participants
N/A N=5 Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Obesity
Primary: Fat Absorption — 60.6 g/d — p=<0.05
Phase 3 N=49 Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
Parkinson's Disease
Primary: Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO) — 2; 12; 2; 9 participants — p=1.0
Phase 3 N=69 Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer
Rectal Cancer
Primary: Number of Participants Who Completed MSKCC Bowel Function Instrument (BFI Score) in Patients Following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for…
Phase 4 N=15 rHGH and Intestinal Permeability in Intestinal Failure
Short Bowel Syndrome
Primary: To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®). — 7 participants
Phase 4 N=120 Sugammadex To IMprove Bowel Function
Bowel Dysfunction · Postoperative Complications · Neuromuscular Blockade
Primary: Gastric Emptying — 1120; 1130 log(ng*ml-1)*min — p=0.58
N/A N=17 Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)
Diarrhea Predominant Irritable Bowel Syndrome
Primary: Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item. — 13 Participants
N/A N=9 Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Bloodstream Infections · Short Bowel Syndrome · Development
Primary: Number of Participants With Bloodstream Infections (BSI) — 0; 1 Participants
Phase 3 N=11 An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
Short Bowel Syndrome
Primary: Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume — 3; 5 Participants
Phase 3 N=3 A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
Short Bowel Syndrome
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 3 Participants
N/A N=50 The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea
Primary: Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. — .46; .21 bowel movements/day