Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
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.
Colon Nos Polypectomy Tubular Adenoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy|
- The proportion of patients had no or mild peristalsis during the therapeutic procedures [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]No or mild gastric peristalsis is defined as when patients have no or suppressed gastric peristalsis during the therapeutic procedure (for 45 s). The degree of gastric peristalsis in the time periods is assessed by an independent committee.
- Duration of peristalsis-suppressing effect [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
- Difficulty level of the therapeutic procedure [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
- Adverse events and adverse drug reactions [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411189
|Nihon Pharmaceutical Co., Ltd|
|Tokyo, Japan, 101-0031|