Clinical trials: Lower Gastrointestinal Disorder
- Condition Lower Gastrointestinal Disorder
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Refractory Reflux Esophagitis
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of…
- Trial name
- NCT01669811
- Testing
- Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
- Where
- 63 sites in Japan
- Volunteers
- 1,398 people
- Sponsor
- AstraZeneca
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Reflux Episodes
TLESR-impedance Study in Patients
The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.
- Trial name
- NCT00743444
- Testing
- AZD3355
- Volunteers
- 27 people
- Sponsor
- AstraZeneca
Venous Insufficiency, Venous Reflux
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers.
- Conditions
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- Trial name
- NCT01549860
- Testing
- MIST Therapy
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Celleration, Inc.
Cystic Fibrosis
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution.
- Trial name
- ELITE (NCT00391976)
- Testing
- Tobramycin solution for inhalation 300 mg
- Volunteers
- 123 people
- Sponsor
- Novartis
Graft Versus Host Disease
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI…
- Trial name
- NCT02956122
- Testing
- GLASSIA, methylprednisolone or equivalent steroid, Albumin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Baxalta now part of Shire
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Overactive Bladder, Fecal Incontinence
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
- Conditions
- Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention
- Trial name
- ELITE (NCT04506866)
- Testing
- InterStim Micro
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 148 people
- Sponsor
- MedtronicNeuro
Urinary Retention, Urinary Urge Incontinence
Axonics SacRal NeuromodulaTIon System RegisTRY Study
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
- Conditions
- Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence
- Trial name
- ARTISTRY (NCT05064384)
- Where
- 27 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Axonics, Inc.
Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD).
- Conditions
- Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal, Gastroesophageal Reflux, Acid Reflux
- Trial name
- NCT02749071
- Testing
- Laparoscopic implantation surgery with or without crural repair, EndoStim stimulation for first six months of study, EndoStim stimulation from Month 6 thru end of study
- Where
- 21 sites in United States, Belgium and 2 more
- Volunteers
- 161 people
- Sponsor
- EndoStim Inc.
Acute Graft vs Host Disease
Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD
A Phase IIa single arm open-label study to investigate the safety, tolerability, and PK of F-652 in combination with systemic corticosteroids in subjects who have undergone Hematopoietic Stem Cell Transplantation (HSCT) and have…
- Trial name
- NCT02406651
- Testing
- Recombinant Human Interleukin-22 IgG2-Fc (F-652), Systemic Corticosteroids
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- EVIVE Biotechnology
Gastro-oesophageal Junction Cancer, Gastric Cancer
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene…
- Trial name
- SHINE (NCT01457846)
- Testing
- AZD4547, paclitaxel
- Where
- 61 sites in Belgium, Bulgaria and 14 more
- Volunteers
- 960 people
- Sponsor
- AstraZeneca
Fecal Incontinence
Autologous Cell Therapy for Treatment of Fecal Incontinence
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment…
- Trial name
- NCT01600755
- Testing
- Iltamiocel
- Where
- 2 sites in Canada, United Kingdom
- Volunteers
- 53 people
- Sponsor
- Cook MyoSite
Acute Graft-Versus-Host Disease, GIGVHD
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower…
- Trial name
- GIGVHD (NCT02245412)
- Testing
- ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly, ALXN1007 20 mg/kg twice weekly
- Where
- 12 sites in United States, France
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals