Clinical trials: Gastro-Intestinal Disorders
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.
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
Advanced Solid Tumors, Glioblastoma
Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors
Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage.
- Conditions
- Advanced Solid Tumors, Glioblastoma, Soft Tissue Sarcoma (Excluding GIST), Endometrial Carcinoma
- Trial name
- NCT02611024
- Testing
- Lurbinectedin, Irinotecan
- Where
- 23 sites in United States, France and 4 more
- Volunteers
- 316 people
- Sponsor
- PharmaMar
Ulcerative Colitis
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.
- Trial name
- OPAL (NCT02808780)
- Where
- 63 sites in United States, Austria and 7 more
- Volunteers
- 535 people
- Sponsor
- Janssen Biotech, Inc.
GERD
Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD
The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.
- Trial name
- NCT00586859
- Testing
- NDO Full-thickness Plicator
- Where
- 4 sites in Germany
- Volunteers
- 41 people
- Sponsor
- NDO Surgical, Inc.
Polymyositis, Dermatomyositis
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or…
- Trial name
- NCT01148810
- Testing
- BAF312
- Where
- 6 sites in United States, Czechia and 3 more
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
Fabry Disease
Study to Evaluate the Safety and EffIcacy of PRX-102 on Gastrointestinal Symptoms in Naïve Fabry Disease
The study will be a randomized, double blind, placebo-controlled study of the safety and efficacy of PRX-102 in ERT naïve male patients randomized 1:1. Patient age will be 14 to 45 years.
- Trial name
- NCT02921620
- Testing
- PRX-102
- Sponsor
- Protalix
Heartburn
Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn
Remote un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in subjects with heartburn.
- Trial name
- NCT05363618
- Testing
- Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)
- Where
- United States
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Microbiome Health Sciences
Reflux Oesophagitis
Effect of Single Doses of YF476 on Stomach Acidity Compared With Ranitidine and Placebo in Fasted and Fed States
The objectives of the study were: To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect to their effects on basal- and food- stimulated gastric pH in healthy volunteers.
- Trial name
- NCT01538797
- Testing
- YF476, Ranitidine
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Trio Medicines Ltd.
Iron Deficiency (Without Anemia)
Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting…
- Trial name
- NCT05257343
- Testing
- Liquid Iron Supplement (Blood Builder ®)
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Applied Science & Performance Institute
Solid Tumor, Hepatocellular Carcinoma
Intravenous T3011 Given as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors
A Phase 1/2a Open-Label Dose Escalation and Dose Expansion Study of T3011 when Administered Intravenously as a Single Agent and in Combination with Other Therapy in Subjects with Advanced Solid Tumors
- Conditions
- Solid Tumor, Hepatocellular Carcinoma, Colorectal Cancer, NSCLC
- Trial name
- NCT04780217
- Testing
- T3011
- Where
- 6 sites in United States
- Volunteers
- 42 people
- Sponsor
- ImmVira Pharma Co. Ltd
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
- Trial name
- NCT00300755
- Testing
- pantoprazole sodium enteric-coated spheroid
- Where
- 43 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer
CT-95 in Advanced Cancers Associated With Mesothelin Expression
This is a Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with…
- Conditions
- Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced, Malignant Peritoneal Mesothelioma, Advanced
- Trial name
- NCT06756035
- Testing
- CT-95
- Where
- 9 sites in United States
- Volunteers
- 70 people
- Sponsor
- Context Therapeutics Inc.
Gastroesophageal Reflux Disease
Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the Gastroesophageal Reflux Disease
This superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease.
- Trial name
- PANDA (NCT01710462)
- Testing
- Pantoprazole + Domperidone, Pantozol®
- Where
- 8 sites in Brazil
- Sponsor
- Eurofarma Laboratorios S.A.
Advanced Solid Cancers
A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9
The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are.
- Trial name
- NCT07186842
- Testing
- BNT329, CA19-9-targeting monoclonal antibody
- Where
- 18 sites in United States, Australia and 3 more
- Volunteers
- 245 people
- Sponsor
- BioNTech SE
Gastro Esophageal Reflux
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.
- Trial name
- NCT06025773
- Testing
- Lansoprazole 15 mg, Lansoprazole 15mg/Calcium carbonate 600mg
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
GERD (Gastroesophageal Reflux Disease)
A Blinded Randomized Clinical Study of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of GERD
This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.
- Trial name
- RENEW RCT (NCT07004400)
- Testing
- RefluxStop™ implantation, Nissen fundoplication
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Implantica CE Reflux Ltd.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics
Indigestion, Dyspepsia
A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
The goal of this observational study is to evaluate if Danning Tablets are effective in alleviating dyspepsia in patients with any of the following digestive symptoms: upper abdominal pain, bloating, loss of appetite, acid reflux…
- Conditions
- Indigestion, Dyspepsia, Bloating, Loss of Appetite
- Trial name
- NCT06755671
- Testing
- Danning Tablet
- Where
- China
- Volunteers
- 4,500 people
- Sponsor
- Shanghai Hutchison Pharmaceuticals Limited
Fecal Incontinence
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal…
- Trial name
- DigniFI (NCT05776277)
- Testing
- Iltamiocel
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Cook MyoSite
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