Clinical trials: Acute Gastroenteritis
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
Appendicitis Acute, Appendicitis
Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis
This will be an explorative, proof-of-principle, open, multi-center investigation. The investigation aims to investigate the safety of the PERIsign system and the ability of physicians to differentiate between healthy individuals…
- Conditions
- Appendicitis Acute, Appendicitis, Abdominal Pain, Peritonitis
- Trial name
- PeriSaFe01 (NCT06296953)
- Testing
- PERIsign examination
- Where
- 2 sites in Sweden
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- STB INN AB
LRTI, UTI
Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections
This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a…
- Conditions
- LRTI, UTI, Gastroenteritis, Systemic Infections/Bacteremia/Meningitis
- Trial name
- CURIOSITY (NCT01917461)
- Where
- 2 sites in Israel
- Volunteers
- 1,001 people, healthy volunteers welcome
- Sponsor
- MeMed Diagnostics Ltd.
Ulcerative Colitis
Safety and Efficacy of Interferon-Beta-1a (Rebif®) for Treating Subjects With Acute Symptoms of Ulcerative Colitis
The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in subjects with active ulcerative colitis (UC).
- Trial name
- NCT00303381
- Testing
- Interferon-beta-1a, 44 microgram, Interferon-beta-1a, 66 microgram
- Where
- 7 sites in Germany, Israel and 5 more
- Volunteers
- 194 people
- Sponsor
- EMD Serono
Ulcerative Colitis (UC), Ulcerative Colitis (Disorder)
A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult
A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in…
- Conditions
- Ulcerative Colitis (UC), Ulcerative Colitis (Disorder), Ulcerative Colitis Acute, IBD (Inflammatory Bowel Disease)
- Trial name
- NCT07632573
- Testing
- BDHK-2009 Tablets
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Benethera (Shaoxing) Biotechnology Co., Ltd.
Acute Bacterial Gastroenteritis
Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of patients with acute bacterial gastroenteritis (traveler's diarrhea.
- Trial name
- NCT00448422
- Testing
- prulifloxacin
- Where
- India
- Volunteers
- 268 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Abscess, Intra-Abdominal, Abdominal Abscess
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.
- Conditions
- Abscess, Intra-Abdominal, Abdominal Abscess, Abdomen, Acute, Abdominal Pain
- Trial name
- NCT01110382
- Testing
- Doripenem, Meropenem, Amoxicillin/clavulanate potassium
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 41 people
- Sponsor
- Janssen Research & Development, LLC
Gastroenteritis
A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis
The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG)…
- Trial name
- NCT02699385
- Testing
- Oral Rehydration Therapy, Domperidone
- Where
- 29 sites in Austria, Belgium and 4 more
- Volunteers
- 10 people
- Sponsor
- Janssen-Cilag International NV
Hematologic Malignancies
Efficacy Study of a TXA127 to Reduce Graft-vs-Host Disease in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing allogeneic peripheral blood stem cell transplantation…
- Trial name
- NCT01882387
- Testing
- TXA127
- Where
- 2 sites in United States
- Sponsor
- Tarix Pharmaceuticals
Acute Gastroenteritis
Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children
Primary Objective: To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute…
- Trial name
- cadiLAc (NCT02169817)
- Testing
- Bacillus clausii, Oral Rehydration Therapy
- Where
- 11 sites in Argentina, Brazil and 3 more
- Volunteers
- 629 people
- Sponsor
- Sanofi
Acute Gastroenteritis
A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay
The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.
- Trial name
- NCT02092259
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- Luminex Corporation
Rotaviral Gastroenteritis
Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates
The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates.
- Trial name
- NCT01201252
- Testing
- Stool sampling
- Where
- 3 sites in United Arab Emirates
- Volunteers
- 717 people
- Sponsor
- GlaxoSmithKline
Diarrhea, Gastroenteritis
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria.
- Conditions
- Diarrhea, Gastroenteritis, Bacterial Infection, Acute Diarrhea
- Trial name
- NCT07285785
- Testing
- Rifaximin 200 mg Tablet, Oral Rehydration Therapy (ORT)
- Where
- 10 sites in United States
- Volunteers
- 54 people
- Sponsor
- Bausch Health Americas, Inc.
Diverticulitis
Asacol Acute Diverticulitis(DIVA)Study
The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.
- Trial name
- NCT00554099
- Testing
- Mesalamine, Probiotic, Dietary Advice
- Where
- 36 sites in United States
- Volunteers
- 117 people
- Sponsor
- Warner Chilcott
Gastroenteritis
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
Primary: To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children Secondary: To evaluate the safety of Enterogermina® in acute diarrhea in Indian children
- Trial name
- ENIGMA (NCT00457353)
- Testing
- Bacillus Clausii, Oral rehydration therapy
- Where
- India
- Volunteers
- 264 people
- Sponsor
- Sanofi
Ulcerative Colitis
Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative…
- Trial name
- NCT01059344
- Testing
- Mesalamin
- Where
- 31 sites in Belarus, India and 2 more
- Volunteers
- 281 people
- Sponsor
- Tillotts Pharma AG
Acute Coronary Syndrome, Myocardial Infarction
Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)
The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer…
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention
- Trial name
- COGENT-1 (NCT00557921)
- Testing
- CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin, Plavix (clopidogrel 75 mg) and aspirin
- Where
- 491 sites in United States, Australia and 14 more
- Volunteers
- 5,000 people
- Sponsor
- Cogentus Pharmaceuticals
Norovirus Acute Gastroenteritis
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age.
- Trial name
- NCT05992935
- Testing
- mRNA-1403, mRNA-1405
- Where
- 16 sites in United States, Australia
- Volunteers
- 1,407 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Ulcerative Colitis
User Surveillance in Ulcerative Colitis
The aim of the non-interventional study is to document the daily doses in acute and remission therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage forms are added and, when and how long steroids are…
- Trial name
- CARE (NCT01363453)
- Where
- 105 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Ferring Pharmaceuticals
Infectious Gastroenteritis
Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious…
- Trial name
- IMPACT (NCT02248285)
- Testing
- FilmArray™ Gastrointestinal (GI) Panel
- Where
- 5 sites in United States
- Volunteers
- 1,545 people
- Sponsor
- BioFire Diagnostics, LLC