Clinical trials: Digestive Disease
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF2 (NCT00104520)
- Testing
- AZLI 75 mg two times a day (BID)/three times a day (TID)
- Where
- 56 sites in United States
- Volunteers
- 211 people
- Sponsor
- Gilead Sciences
Post-ERCP Acute Pancreatitis
Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis.
- Trial name
- IND+LRPEP (NCT02641561)
- Testing
- Indomethacin, Lactated Ringer's Solution, Normal Saline
- Where
- United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- The Cooper Health System
Impaired Liver Function
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
- Trial name
- NCT00741273
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Fatty Liver
Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
Multicenter, randomized, double-blinded, placebo-controlled clinical trial is focused on novel treatments for non-alcoholic fatty liver disease (NAFLD), the most common cause of chronic liver disease.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Fatty Liver, Non-Alcoholic Steatohepatitis
- Trial name
- PUVENAFLD (NCT04198805)
- Testing
- Vitamin E [(all-rac)-α-tocopheryl acetate], Omega-3 fatty acid (DHA EE), Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate]
- Where
- 15 sites in United States
- Volunteers
- 205 people
- Sponsor
- Naga P. Chalasani
Hepatic Cancer
A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy
This phase II study aims to evaluate regional chemotherapy in patients with unresectable primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered…
- Trial name
- NCT00587067
- Testing
- FLOXURIDINE
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Multiple Sclerosis, Constipation
Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
The purpose of the study is to assess how safe and effective the drug Lubiprostone is in people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation.
- Trial name
- NCT01236534
- Testing
- Lubiprostone
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Rochester
HBV (Hepatitis B Virus), Hepatitis B
Lamivudine and Adefovir to Treat Chronic Hepatitis B
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection.
- Conditions
- HBV (Hepatitis B Virus), Hepatitis B, Hepatitis
- Trial name
- NCT00023309
- Testing
- Lamivudine and adefovir, Adefovir alone
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
- Trial name
- STELLAR-4 (NCT03053063)
- Testing
- SEL
- Where
- 283 sites in United States, Australia and 20 more
- Volunteers
- 883 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
Safety and PK Study of MP-424 to Treat Chronic Hepatitis C
The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.
- Trial name
- NCT00591214
- Testing
- MP-424 (Telaprevir)
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Tanabe Pharma Corporation
Appendicitis
Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis
Recent advances in laparoscopic instrumentation have made it possible to perform intra-abdominal operations entirely through a small incision that can be hidden within the umbilicus.
- Trial name
- NCT00997516
- Testing
- SILS appendectomy, conventional laparoscopic appendectomy
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- University of California, San Francisco
Cystic Fibrosis
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to…
- Trial name
- NCT05090904
- Testing
- Brensocatib
- Where
- 14 sites in United States
- Volunteers
- 29 people
- Sponsor
- Insmed Incorporated
Nonalcoholic Steatohepatitis
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).
- Trial name
- NCT01066364
- Testing
- Colesevelam Hcl
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- University of California, San Diego
Hepatitis B
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®.
- Trial name
- NCT04490499
- Testing
- HBVAXPRO™
- Where
- 10 sites in Finland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6…
- Trial name
- NCT02953314
- Testing
- TEZ, TEZ/IVA, IVA
- Where
- 33 sites in United States, Canada
- Volunteers
- 83 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Post-ERCP Pancreatitis
Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis
It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde…
- Trial name
- NCT01912716
- Testing
- high dose indomethacin, standard dose indomethacin
- Where
- 6 sites in United States
- Volunteers
- 1,037 people
- Sponsor
- Indiana University
Advanced Malignancies, Metastatic Cancer
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
- Trial name
- NCT03277352
- Testing
- INCAGN01876, Epacadostat, Pembrolizumab
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Incyte Biosciences International Sàrl
Hepatitis B, Chronic
A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)
This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg] positive or negative) who have not previously been…
- Trial name
- NCT01641926
- Testing
- PEG-Intron™, PEGASYS™
- Volunteers
- 402 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection
- Trial name
- PARTNER (NCT00512278)
- Testing
- Infliximab
- Where
- 7 sites in United States
- Volunteers
- 146 people
- Sponsor
- Nizar Zein
Bowel; Disease, Carbohydrate Absorption, Difficulty Walking
A Trial of Preoperative CHO Drinks on Postoperative Walking Capacity in Colorectal Surgery
This prospective randomized controlled study is designed to investigate whether preoperative oral carbohydrate loading improves postoperative walking performance, a surrogate indicator for overall functional recovery, in patients…
- Conditions
- Bowel; Disease, Carbohydrate Absorption, Difficulty Walking, Colorectal Neoplasms
- Trial name
- NCT01844375
- Testing
- Carbohydrate group, Control group
- Where
- Thailand
- Volunteers
- 70 people
- Sponsor
- Mingkwan Wongyingsinn, MD
Pancreatic Cancer
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12…
- Trial name
- NCT00336700
- Testing
- Gemcitabine, Erlotinib
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Herbert J. Zeh, III MD, FACS
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