Clinical trials: Gastrointestinal and Digestive Disorder
Pancreatic Disease
A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
The following are the study hypothesis: Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when…
- Trial name
- CRC2006-05 (NCT01087801)
- Testing
- ChiRhoStim
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- ChiRhoClin, Inc.
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
Gut Health
Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms
- Trial name
- NCT06419231
- Testing
- Butyrate Formulation, Butyrate + Polyphenol Formulation
- Where
- United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Supplement Formulators, Inc.
Cystic Fibrosis
GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis
This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate GLPG2737 administered orally b.i.d.
- Trial name
- PELICAN (NCT03474042)
- Testing
- GLPG2737
- Where
- 9 sites in Germany
- Volunteers
- 22 people
- Sponsor
- Lakefront Biotherapeutics NV
Solid Tumors, Pancreatic Cancer
Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
- Trial name
- NCT01858883
- Testing
- itacitinib, Gemcitabine, nab-paclitaxel
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Incyte Corporation
Alpha 1-Antitrypsin Deficiency
Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype
This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-814 in PiZZ subjects.
- Trial name
- NCT04167345
- Testing
- VX-814
- Where
- 28 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis B
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in…
- Trial name
- NCT00697931
- Testing
- Recombinant MPL- adjuvanted hepatitis B vaccine, Engerix™-B
- Where
- Belgium
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Metastatic Pancreatic Cancer
A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients…
- Trial name
- NCT06532331
- Testing
- ONO-7475, ONO-4538, Nab-paclitaxel
- Where
- 9 sites in Japan
- Volunteers
- 87 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Gastroesophageal Reflux Disease
Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from Gastroesophageal Reflux Disease (GERD).
- Trial name
- NCT01574339
- Testing
- EndoStim LES Stimulation System
- Where
- 10 sites in Chile, Colombia and 6 more
- Volunteers
- 42 people
- Sponsor
- EndoStim Inc.
Inflammatory Bowel Disease, Perianal Fistula
Perianal Fistula (PAF) Validation and Burden of Illness Study
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
- Conditions
- Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
- Trial name
- NCT03981939
- Testing
- No intervention
- Where
- Canada
- Volunteers
- 3,032 people
- Sponsor
- Takeda
Ulcerative Colitis (UC)
Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis
An open-label, randomised, multi-centre, dose evaluation study of the efficacy and safety of TLA Gut™ leukapheresis treatment in patients with UC.
- Trial name
- NCT04550130
- Testing
- TLA Gut™
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- TLA, Targeted Immunotherapies AB
Colorectal Neoplasms
An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.
- Trial name
- NCT01134666
- Testing
- Cetuximab
- Where
- 40 sites in India
- Volunteers
- 165 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Colorectal Cancer (CRC)
Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
- Trial name
- NCT00851045
- Testing
- Irinotecan, 5-Fluorouracil (bolus), 5-Fluorouracil (infusional)
- Where
- 15 sites in United States, Argentina and 1 more
- Volunteers
- 17 people
- Sponsor
- Bristol-Myers Squibb
Cystic Fibrosis
Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)
Monoglyceride of DHA (DHA-MAG) is a lipid compound for which intestinal absorption would increase the ratio DHA / arachidonic acid (AA) and promote the synthesis of specific metabolites involved in the resolution of inflammation.
- Trial name
- PREMDIC (NCT02518672)
- Testing
- MAG-DHA
- Where
- Canada
- Volunteers
- 11 people
- Sponsor
- SCF Pharma
NASH, Cirrhosis, Liver
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical…
- Trial name
- NCT05500222
- Testing
- Resmetirom
- Where
- 141 sites in United States, Belgium and 7 more
- Volunteers
- 845 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Drug Interaction, GERD (Gastroesophageal Reflux Disease)
A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin
This is an open, single arm, single-center Phase I trial designed to evaluate the effect of seven days repeated oral doses of linaprazan glurate on the pharmacokinetics (PK) of repeated doses of amoxicillin in healthy male and…
- Conditions
- Drug Interaction, GERD (Gastroesophageal Reflux Disease), Safety, and Tolerability
- Trial name
- NCT07308041
- Testing
- Drug Drug Interaction
- Where
- Sweden
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Trial name
- REVERSE (NCT03439254)
- Testing
- Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg)
- Where
- 192 sites in United States, Australia and 10 more
- Volunteers
- 919 people
- Sponsor
- Intercept Pharmaceuticals
Hepatocellular Carcinoma
Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized…
- Trial name
- OPTIMA (NCT02112656)
- Testing
- ThermoDox, Dummy infusion
- Where
- 61 sites in United States, Canada and 12 more
- Volunteers
- 554 people
- Sponsor
- Imunon
Squamous Cell Carcinoma of the Anal Canal
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.
- Trial name
- NCT04472429
- Testing
- carboplatin, paclitaxel, retifanlimab
- Where
- 84 sites in United States, Australia and 11 more
- Volunteers
- 308 people
- Sponsor
- Incyte Corporation
Clear Cell Renal Cell Carcinoma, Cervical Carcinoma
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.
- Conditions
- Clear Cell Renal Cell Carcinoma, Cervical Carcinoma, Esophageal Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT05795595
- Testing
- CTX131
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- CRISPR Therapeutics AG
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