Clinical trials: Lower Gastrointestinal Tract
- Condition Lower Gastrointestinal Tract
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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
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.
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
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
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
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
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.