Clinical trials: Digestion
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF…
- Trial name
- NCT03447249
- Testing
- VX-659/TEZ/IVA, IVA
- Where
- 101 sites in United States, Australia and 9 more
- Volunteers
- 385 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Stomach Neoplasms
A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antitumor response of ramucirumab in combination with platinum/fluoropyrimidine regimens in Japanese participants with advanced…
- Trial name
- NCT02359058
- Testing
- Ramucirumab, Capecitabine, Cisplatin
- Where
- 4 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Eli Lilly and Company
Familial Adenomatous Polyposis
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)
The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of…
- Trial name
- NCT01483144
- Testing
- Eflornithine, Sulindac 150 MG
- Where
- 17 sites in United States, Belgium and 5 more
- Volunteers
- 171 people
- Sponsor
- Cancer Prevention Pharmaceuticals, Inc.
Cystic Fibrosis
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF…
- Trial name
- NCT03525444
- Testing
- VX-445/TEZ/IVA, IVA
- Where
- 115 sites in United States, Australia and 11 more
- Volunteers
- 405 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Colorectal Cancer
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic…
- Trial name
- NCT03555149
- Testing
- Regorafenib, Atezolizumab, Imprime PGG
- Where
- 15 sites in United States, Australia and 3 more
- Volunteers
- 96 people
- Sponsor
- Hoffmann-La Roche
Pancreatic Carcinoma
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for…
- Trial name
- NCT01774019
- Testing
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Where
- 11 sites in United States, Australia and 7 more
- Volunteers
- 284 people
- Sponsor
- Boston Scientific Corporation
Gastrointestinal Neoplasms; Esophageal, Stomach, Pancreas, Colon Neoplasms; Malignant Tumors of Digestive Organ; Advanced Gastrointestinal Malignancies
A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.
- Trial name
- NCT03449030
- Testing
- TAK-164, 89Zr-TAK-164
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Neoplasms, Carcinoma, Non-Small-Cell Lung
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.
- Conditions
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
- Trial name
- NCT03948763
- Testing
- V941, Pembrolizumab
- Where
- 26 sites in United States, Australia and 5 more
- Volunteers
- 70 people
- Sponsor
- Merck Sharp & Dohme LLC
Barrett's Esophagus
Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation
This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who achieved complete eradication of Barrett's…
- Trial name
- NCT02162758
- Testing
- Dexlansoprazole
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Takeda
Gastroesophageal Reflux Disease (GERD)
The EndoGastric Solutions TEMPO Trial
The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal…
- Trial name
- TEMPO (NCT01647958)
- Testing
- EsophyX System with SerosaFuse fasteners, PPI
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- EndoGastric Solutions
Metastatic Colorectal Cancer
Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects
To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.
- Trial name
- NCT00865709
- Testing
- Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
- Where
- 116 sites in United States, Belgium and 8 more
- Volunteers
- 198 people
- Sponsor
- Bayer
Bowel Obstruction
A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly…
- Trial name
- IMPROVE-Open (NCT01507233)
- Testing
- IV morphine sulfate, EXPAREL (bupivacaine liposome injectable suspension)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Crohn's Disease
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.
- Trial name
- NCT01470599
- Testing
- CP-690,550
- Where
- 75 sites in United States, Australia and 15 more
- Volunteers
- 150 people
- Sponsor
- Pfizer
Crohn's Disease
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region…
- Trial name
- NCT01514240
- Testing
- D9421-C capsule 3 mg, Mesalazine tablets
- Where
- 25 sites in Japan
- Volunteers
- 123 people
- Sponsor
- AstraZeneca
Colorectal Neoplasms
A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer
This open-label, prospective, single-arm, multicenter study will evaluate the relationship of the markers of inflammation and progression-free survival (PFS) in participants with previously untreated metastatic colorectal cancer.
- Trial name
- ASCENT (NCT01588990)
- Testing
- Oxaliplatin, Capecitabine, Bevacizumab
- Where
- 17 sites in Australia
- Volunteers
- 128 people
- Sponsor
- Hoffmann-La Roche
Crohn Disease, Ulcerative Colitis
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the…
- Conditions
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Trial name
- ReFLECT (NCT02925338)
- Testing
- QOL questionaire
- Where
- 67 sites in France
- Volunteers
- 1,431 people
- Sponsor
- Pfizer
Gastric Cancer
Pemetrexed Plus Cisplatin as First-Line Treatment in Stage IV or Recurrence of Gastric Cancer
Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not amenable to curative surgery, or recurrence after…
- Trial name
- NCT00415168
- Testing
- pemetrexed, cisplatin
- Where
- 6 sites in Russia
- Volunteers
- 53 people
- Sponsor
- Eli Lilly and Company
Hepatitis C, Chronic
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic…
- Trial name
- NCT02765490
- Testing
- AL-335, Odalasvir, Simeprevir
- Where
- 28 sites in Belgium, Canada and 4 more
- Volunteers
- 365 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis…
- Trial name
- ASTRAL-1 (NCT02201940)
- Testing
- SOF/VEL
- Where
- 80 sites in United States, Belgium and 7 more
- Volunteers
- 741 people
- Sponsor
- Gilead Sciences
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