Clinical trials: Gastro-Intestinal Disorders
GIST and CML
Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator
This Phase IV, open-label, multicenter roll-over study evaluated the long-term safety of imatinib in patients who had completed a previous Novartis-sponsored imatinib study and were considered by the investigator to continue…
- Trial name
- NCT01742299
- Testing
- imatinib mesylate
- Where
- 29 sites in United States, China and 9 more
- Volunteers
- 155 people
- Sponsor
- Novartis Pharmaceuticals
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
Rectal Cancer Stage III, Lung Cancer Stage III
Bovine Reinforcement in Stomach, Colorectal and Lung Operation
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material…
- Trial name
- NCT06968221
- Testing
- Bioabsorbable Staple Line Reinforcemen
- Where
- China
- Volunteers
- 172 people
- Sponsor
- Shanghai Cingularbio Co. Ltd
Aortic Valve Disorder, Aortic Valve Insufficiency
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
- Conditions
- Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure
- Trial name
- NCT01651052
- Testing
- Heart Valve Surgery
- Where
- 2 sites in Poland
- Volunteers
- 133 people
- Sponsor
- Edwards Lifesciences
Systemic Lupus Erythematosus, Arthritic Psoriasis
A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation
The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165…
- Conditions
- Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis, Inflammatory Bowel Diseases
- Trial name
- NCT03254784
- Testing
- BMS-986165 Capsule, BMS-986165 Tablet
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Cancer
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC)…
- Trial name
- NCT02034110
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Austria and 12 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Gastroesophageal Reflux
Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease
This is a remote study. No office visits required. The purpose and efficacy endpoint of this study is to assess whether GERD patients tolerate ISOT-101.
- Trial name
- NCT04491734
- Testing
- maltosyl-isomalto-oligosaccharides (MIMO)
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- ISOThrive Inc.
Advanced Solid Tumors, HR+ Breast Cancer
(VELA) Study of BLU-222 in Advanced Solid Tumors
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.
- Conditions
- Advanced Solid Tumors, HR+ Breast Cancer, CCNE1 Amplification, HER2-negative Breast Cancer
- Trial name
- NCT05252416
- Testing
- BLU-222, Carboplatin, Ribociclib
- Where
- 23 sites in United States, Italy and 1 more
- Volunteers
- 50 people
- Sponsor
- Blueprint Medicines Corporation
Gastroesophageal Reflux
Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment
The primary objective of the study is to describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(using GerdQ questionnaire).
- Trial name
- NCT01103804
- Where
- 19 sites in Romania
- Volunteers
- 952 people
- Sponsor
- AstraZeneca
GERD
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months.
- Trial name
- NCT00241514
- Testing
- Esomeprazole
- Where
- 113 sites in United States, Belgium and 4 more
- Volunteers
- 334 people
- Sponsor
- AstraZeneca
Inflammatory Bowel Disease, Anemia
FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR
The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.
- Conditions
- Inflammatory Bowel Disease, Anemia, Iron Deficiency, Iron-Deficiency Anemia
- Trial name
- FER-IBD-COR (NCT00810030)
- Testing
- Ferric carboxymaltose, Iron Sucrose
- Where
- Austria
- Volunteers
- 484 people
- Sponsor
- Vifor Pharma
Niemann-Pick Disease, Type C
VTS-270 to Treat Niemann-Pick Type C1 (NPC1) Disease
Due to different study designs, the sponsor separated Part C into a separate registration (NCT04958642), leaving Parts A/B here in NCT02534844.
- Trial name
- NCT02534844
- Testing
- Parts A/B: Adrabetadex
- Where
- 29 sites in United States, Australia and 7 more
- Volunteers
- 56 people
- Sponsor
- Mandos LLC
Crohn's Disease, Inflammatory Bowel Disease
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
- Trial name
- NCT01009281
- Testing
- AIN457
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Double Cord Blood Transplant, Acute Myelogenous Leukemia
TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation
The purpose of this study is to evaluate the effect of TXA127 on neutrophil and platelet counts in adult patients who have undergone a double cord blood transplant.
- Conditions
- Double Cord Blood Transplant, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Myelofibrosis
- Trial name
- USBTXA127CBT (NCT01300611)
- Testing
- TXA127 300 mcg/kg/day, TXA127 1000 mcg/kg/day
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Tarix Pharmaceuticals
Gastric Ulcer
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at…
- Trial name
- NCT01129011
- Testing
- PN400 (VIMOVO), Naproxen
- Volunteers
- 420 people
- Sponsor
- POZEN
ER+ Breast Cancer, Ovarian Cancer
Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumor, Including a Cohort Expansion in Esophageal Cancer.
This Phase 1b is a dose escalation, MTD expansion and cohort expansions study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors.
- Conditions
- ER+ Breast Cancer, Ovarian Cancer, Cervical Squamous Cell Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT03983954
- Testing
- Obinutuzumab, naptumomab estafenatox and durvalumab, Naptumomab estafenatox and durvalumab
- Where
- 9 sites in India, Israel
- Volunteers
- 120 people
- Sponsor
- NeoTX Therapeutics Ltd.
Health, Subjective, Gastrointestinal Dysfunction
Personal Lifestyle Engine (PLX) - Personal Lifestyle Medicine Center (PLMC)
It has been suggested that the best medicine should include four principles (4P) - Medicine should be personalized, predictive, preventative and participatory.
- Conditions
- Health, Subjective, Gastrointestinal Dysfunction, Cardiovascular Risk Factor, Autoimmune Diseases
- Trial name
- NCT04007939
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Metagenics, Inc.
Barrett Esophagus, Gastroesophageal Reflux
The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry
The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food…
- Conditions
- Barrett Esophagus, Gastroesophageal Reflux, Esophageal Dysplasia, Esophageal Diseases
- Trial name
- NCT02988934
- Where
- United States
- Volunteers
- 3,173 people
- Sponsor
- CDx Diagnostics
Ulcerative Colitis
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
- Trial name
- PACE (NCT02093663)
- Testing
- MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Shire
Gastric or Duodenal Ulcer
A Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" Under Fed Conditions in Healthy Adult Volunteers
The purpose of this clinical trial is evaluate the pharmacokinetics and safety between single administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fed conditions in healthy adult volunteers
- Trial name
- NCT05959499
- Testing
- BR6002A, BR6002B, BR6002
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
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