Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal ā¦ (NCT01411189) | Clinical Trial Compass
CompletedPhase 3
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
Japan33 participantsStarted 2011-09
Plain-language summary
Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy, endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic therapeutic procedures will be evaluated based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee.
The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
ā. Patients who require therapeutic upper gastrointestinal endoscopy (polypectomy, endoscopic hemostasis, PEG, EMR and ESD)
ā. Patients with a differentiated-type intramucosal gastric cancer located in the upper or middle third of the stomach (ā¤2 cm in size, no ulcer finding, EMR or ESD)
ā. Patients with a gastric adenoma (ā¤2 cm in size, no ulcer finding, EMR or ESD)
ā. Patients with an a single intended lesion for the treatment
ā. Patients without experience of PEG tube placement in case of PEG tube placement
ā. Patients who are older than 20 years at the time of consent
Exclusion criteria
ā. Patients with a history of surgery to the upper gastrointestinal tract
ā. Patients who require emergency endoscopy
ā. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
What they're measuring
1
The proportion of patients had no or mild peristalsis during the therapeutic procedures