Gastroenterology & Hepatology Clinical Trials

Statistical methods in gastroenterology & hepatology trials

The methods these trials rely on most, based on the statistical analyses posted to ClinicalTrials.gov, with the tutorial that explains each one.

All gastroenterology & hepatology trials

642 results

• Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00737594).Phase 2Results postedn = 9NCT00737594
• Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096): Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096): primary endpoint results, effect…Phase 4Results postedn = 117NCT03111108
• Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 2Results postedn = 1NCT03139032
• Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy: primary…Phase 3Results postedn = 32NCT00781274
• Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 33NCT00912743
• Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…Phase 2Results postedn = 137NCT00573131
• Efficacy and Safety of Oral BT-11 in Ulcerative Colitis: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Oral BT-11 in Ulcerative Colitis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03861143).Phase 2Results postedn = 198NCT03861143
• Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…Phase 2Results postedn = 38NCT03020095
• Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 2Results postedn = 266NCT01479465
• Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults: primary endpoint results,…Phase 3Results postedn = 224NCT01667731
• Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 3Results postedn = 375NCT02671500
• Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study: Complete Statistical AnalysisIndependent statistical analysis of Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study: primary endpoint results,…Phase 2Results postedn = 69NCT02300103
• Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 87NCT01746095
• Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 – Proteinase Inhibitor): Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…Phase 4Results postedn = 21NCT00396006
• Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 2Results postedn = 29NCT02273596
• Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn’s Disease: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 2Results postedn = 69NCT02531113
• Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson’s Disease in Japan.: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 3Results postedn = 37NCT00212355
• Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis: Complete Statistical AnalysisIndependent statistical analysis of Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase 2Results postedn = 18NCT01148810
• Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery: Complete Statistical AnalysisIndependent statistical analysis of Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase NAResults postedn = 802NCT01233050
• Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy: Complete Statistical AnalysisIndependent statistical analysis of Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…Phase 3Results postedn = 178NCT00847808
• Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis: Complete Statistical AnalysisIndependent statistical analysis of Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00658736).Phase 3Results postedn = 40NCT00658736
• Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer: Complete Statistical AnalysisIndependent statistical analysis of Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00557492).Phase 2Results postedn = 59NCT00557492
• Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016): Complete Statistical AnalysisIndependent statistical analysis of Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016): primary endpoint results, effect estimate with confidence interval, sample-size…Phase 2/3Results postedn = 1,224NCT03537274
• Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®: Complete Statistical AnalysisIndependent statistical analysis of Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 2Results postedn = 15NCT05900050
• Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH): Complete Statistical AnalysisIndependent statistical analysis of Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH): primary endpoint results, effect estimate with confidence interval, sample-size…Phase 2Results postedn = 10NCT03883607
• ELEVATEIndependent statistical analysis of Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures: primary endpoint results, effect estimate with confidence interval,…Phase 3Results postedn = 292NCT00678587
• Eltrombopag Phase III Study In Chinese Chronic ITP Patients: Complete Statistical AnalysisIndependent statistical analysis of Eltrombopag Phase III Study In Chinese Chronic ITP Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01762761).Phase 3Results postedn = 155NCT01762761
• Elucidation of Acid-Induced Pulmonary Inflammation: Complete Statistical AnalysisIndependent statistical analysis of Elucidation of Acid-Induced Pulmonary Inflammation: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00361972).Phase 2/3Results postedn = 17NCT00361972
• EMERALD-2Independent statistical analysis of A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 2Results postedn = 280NCT05611671
• EMPIREIndependent statistical analysis of A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 4Results postedn = 53NCT04118088
• EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients: Complete Statistical AnalysisIndependent statistical analysis of EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients: primary endpoint results, effect estimate with confidence…Phase 2Results postedn = 200NCT02443688
• ENCOREIndependent statistical analysis of Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase NAResults postedn = 2,662NCT00705614
• EndoRings Colonoscopy vs Standard Colonoscopy: Complete Statistical AnalysisIndependent statistical analysis of EndoRings Colonoscopy vs Standard Colonoscopy: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03418662).Phase NAResults postedn = 592NCT03418662
• Endoscopic Therapy of Early Cancer in Barretts Esophagus: Complete Statistical AnalysisIndependent statistical analysis of Endoscopic Therapy of Early Cancer in Barretts Esophagus: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00217087).Phase 2Results postedn = 73NCT00217087
• EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX: Complete Statistical AnalysisIndependent statistical analysis of EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 3Results postedn = 218NCT03126435
• ENDURANCE-2Independent statistical analysis of A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection: primary endpoint results, effect estimate with confidence…Phase 3Results postedn = 304NCT02640482
• ENIGMAIndependent statistical analysis of the ENIGMA phase 3 randomized trial of Bacillus Clausii with oral rehydration therapy for diarrhea in children with gastroenteritis, including trial design, endpoints, planned statistical methods, and interpretation.Phase 3n = 264NCT00457353
• Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B: Complete Statistical AnalysisIndependent statistical analysis of Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 3Results postedn = 669NCT00410072
• Enzastaurin for Patients With Metastatic Colorectal Cancer: Complete Statistical AnalysisIndependent statistical analysis of Enzastaurin for Patients With Metastatic Colorectal Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00192114).Phase 2Results postedn = 28NCT00192114
• EPMCS-CAIndependent statistical analysis of A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase NAResults postedn = 168NCT03326895
• Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients: Complete Statistical AnalysisIndependent statistical analysis of Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 2Results postedn = 15NCT00383760
• Escitalopram to Placebo in Patients With Localized Pancreatic Cancer: Complete Statistical AnalysisIndependent statistical analysis of Escitalopram to Placebo in Patients With Localized Pancreatic Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05289830).Phase 2Results postedn = 4NCT05289830
• Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus: Complete Statistical AnalysisIndependent statistical analysis of Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 2Results postedn = 122NCT00474903
• ESTRELLAIndependent statistical analysis of A Study of Belcesiran in Patients With AATLD: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04764448).Phase 2Results postedn = 16NCT04764448
• Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults: Complete Statistical AnalysisIndependent statistical analysis of Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…Phase 1Results postedn = 16NCT00741273
• Evaluating Online Messages About Colon Cancer Screening: Complete Statistical AnalysisIndependent statistical analysis of Evaluating Online Messages About Colon Cancer Screening: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT06134089).Phase NAResults postedn = 2,210NCT06134089
• Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen: Complete Statistical AnalysisIndependent statistical analysis of Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 3Results postedn = 420NCT01129011
• Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec: Complete Statistical AnalysisIndependent statistical analysis of Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 3Results postedn = 20NCT00594854
• Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection: Complete Statistical AnalysisIndependent statistical analysis of Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection: primary endpoint results, effect…Phase 3Results postedn = 262NCT01482767
• Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations: Complete Statistical AnalysisIndependent statistical analysis of Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase NAResults postedn = 10NCT01517529

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