Clinical trials: GI Disorders
Healthy Subjects
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects
This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only)…
- Trial name
- NCT03980080
- Testing
- OSE-127
- Where
- Belgium
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma
A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
This first-in-human study evaluates safety, tolerability and distribution of [225Ac] FPI-1966, [111In]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.
- Conditions
- Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma, Bladder Carcinoma, Susceptible FGFR3 Genetic Alterations
- Trial name
- NCT05363605
- Testing
- [225Ac]-FPI-1966, [111In]-FPI-1967, vofatamab
- Where
- 6 sites in United States, Australia
- Volunteers
- 6 people
- Sponsor
- Fusion Pharmaceuticals Inc.
Gastric Cancer, Colorectal Cancer
A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with…
- Conditions
- Gastric Cancer, Colorectal Cancer, Pancreatic Cancer, Biliary Cancer
- Trial name
- NCT02908451
- Testing
- AbGn-107
- Where
- 9 sites in United States, Taiwan
- Volunteers
- 39 people
- Sponsor
- AbGenomics B.V Taiwan Branch
Colitis, Ulcerative
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
- Trial name
- NCT00488631
- Testing
- Golimumab 50 mg, Golimumab 100 mg, Golimumab 200 mg
- Where
- 297 sites in United States, Australia and 24 more
- Volunteers
- 1,228 people
- Sponsor
- Janssen Research & Development, LLC
Melanoma, Urothelial Carcinoma
A RC198 Study in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Safety study of RC198 in Subjects with Solid Tumors.
- Conditions
- Melanoma, Urothelial Carcinoma, Renal Cell Carcinoma, Non-small Cell Lung Cancer
- Trial name
- NCT05867303
- Testing
- RC198 Injection
- Where
- 5 sites in Australia, China
- Volunteers
- 48 people
- Sponsor
- RemeGen Co., Ltd.
Anastomotic Leak, Colon Cancer
Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to…
- Conditions
- Anastomotic Leak, Colon Cancer, Right Hemicolectomy
- Trial name
- LICOSARH (NCT07132970)
- Testing
- Monoplus Suture Material
- Where
- 4 sites in Germany
- Volunteers
- 249 people
- Sponsor
- Aesculap AG
Inflammatory Bowel Diseases
ImmuneSense™ IBD Study
This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase.
- Trial name
- NCT05769829
- Where
- 6 sites in United States
- Volunteers
- 484 people, healthy volunteers welcome
- Sponsor
- Adaptive Biotechnologies
Bowel Dysfunction, Constipation
Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo.
- Trial name
- NCT00259922
- Testing
- Alvimopan, Alviompan
- Where
- 187 sites in United States, Australia and 10 more
- Volunteers
- 485 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Crohn's Disease
Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not…
- Trial name
- NCT01510431
- Testing
- PROCHYMAL (remestemcel-L)
- Where
- 4 sites in United States
- Sponsor
- Mesoblast, Inc.
Gastrointestinal Dysfunction, Malnutrition
Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients
This is a prospective two-center observational cohort study in adult patients undergoing major abdominal and/or pelvic oncologic surgery with pre-existing malnutrition.
- Conditions
- Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative, Abdominal Neoplasm
- Trial name
- GIDNUT (NCT07622888)
- Testing
- Serotonin (e.g., serotonin adipinate), Standard Prokinetic Therapy (excluding serotonin)
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Arma Ltd.
Crohn's Disease
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.
- Trial name
- NCT00573469
- Testing
- D9421-C, 9mg, D9421-C, 15mg
- Where
- 22 sites in Japan
- Volunteers
- 75 people
- Sponsor
- AstraZeneca
GERD (Gastroesophageal Reflux Disease)
National Survey on GERD Patients (Adults and Children)
To describe GERD digestive expression according to ages: - children (from 0 to 23 months) and (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40 to 49 years old), (from 50 to 59 years…
- Trial name
- RGO à trav (NCT00833573)
- Where
- 1,053 sites in France
- Volunteers
- 4,400 people
- Sponsor
- AstraZeneca
Advanced Solid Tumor, Gynecologic Cancer
A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
This is an open-label, multicenter, First-In-Human (FIH), Phase 1a/1b study of PY159 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to Standard Of Care (including…
- Conditions
- Advanced Solid Tumor, Gynecologic Cancer, Breast Cancer, Colorectal Cancer
- Trial name
- NCT04682431
- Testing
- PY159 Single agent dose level 1, PY159 Single agent dose level 2, PY159 Single agent dose level 3
- Where
- 17 sites in United States
- Volunteers
- 127 people
- Sponsor
- Ikena Oncology
Shigellosis
Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.
In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old…
- Trial name
- S4V02 (NCT06523231)
- Testing
- Shigella4V2, MenACWY
- Where
- Kenya
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Colonic Diseases, and Large Bowel Diseases
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.
- Trial name
- NCT01063231
- Testing
- PillCam™ (Capsule Endoscopy) Colon 2 capsule
- Where
- 8 sites in Belgium, France and 5 more
- Volunteers
- 119 people
- Sponsor
- Medtronic - MITG
Peritoneal Carcinoma, Colorectal Carcinoma
Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC
This is a phase 1/2a open label study to evaluate the dose, safety, tolerability and efficacy of an IP α-emitting radionuclide therapy (Radspherin®) in subjects with peritoneal carcinomatosis (PC) from colorectal carcinoma…
- Trial name
- NCT03732781
- Testing
- Radspherin
- Where
- 2 sites in Norway, Sweden
- Volunteers
- 47 people
- Sponsor
- Oncoinvent Solutions AS
Colorectal Cancer
Tumour Registry Colorectal Cancer
To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.
- Trial name
- TKK (NCT00910819)
- Where
- Germany
- Volunteers
- 7,000 people
- Sponsor
- iOMEDICO AG
Colorectal Cancer, Polyp, Colonic
Technical Feasibility Evaluation of Mucosal Staining During Colon Capsule Endoscopy (CCE) Procedure in Colorectal Cancer (CRC) High Risk Population, When Using MB-MMX
A prospective, single-center, single-arm, non-randomized, post-market pilot study evaluating the technical feasibility of mucosal staining during COLON2 Capsule Endoscopy (CCE) procedure in population at high risk for Colorectal…
- Trial name
- NCT05022719
- Testing
- PillCam Colon2 procedure with MB-MMX
- Where
- Spain
- Volunteers
- 8 people
- Sponsor
- Medtronic - MITG
Swallowing Disorders
NewBreez Safety and Efficacy Evaluation
The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.
- Trial name
- NCT01587664
- Testing
- NewBreez ILP
- Where
- 2 sites in Belgium, France
- Volunteers
- 2 people
- Sponsor
- ProTiP Medical
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer)
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of [64Cu]Cu-AKY-2519 and/or [225Ac]Ac-AKY-2519, as well as the preliminary anti-tumor activity…
- Conditions
- NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer), ES-SCLC, Small Cell Lung Cancer Extensive Stage
- Trial name
- BActinium-2 (NCT07887971)
- Testing
- [225Ac]Ac-AKY-2519 (therapeutic), [64Cu]Cu-AKY-2519 (imaging)
- Where
- 2 sites in United States
- Volunteers
- 152 people
- Sponsor
- Aktis Oncology, Inc.
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