Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
Patients with early gastric cancer, who require therapeutic upper gastrointestinal endoscopy, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to placebo as anti-peristaltic agent will be verified in a randomized, double-blind, parallel-assignment design 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 in comparison with the placebo group.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III Placebo-controlled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy (Randomized, Double-blind, Parallel-assignment, Placebo-controlled Study)|
- 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. 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 ]
- One-piece resection rate with tumor-free margin [ 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)|
Active Comparator: Menthol
20 ml NPO-11
20 mL NPO-11 in a prefilled plastic syringe
Placebo Comparator: Placebo
20 ml NPO-11(Placebo)
The placebo is included same additives as active comparator.