Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
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|ClinicalTrials.gov Identifier: NCT01411176|
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : June 29, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Menthol Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
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.
- The proportion of patients had no or mild peristalsis during the therapeutic procedures [ Time Frame: 60 minutes ]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 ]
- Difficulty level of the therapeutic procedure [ Time Frame: 60 minutes ]
- One-piece resection rate with tumor-free margin [ Time Frame: 60 minutes ]
- Adverse events and adverse drug reactions [ Time Frame: 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411176
|Nihon Pharmaceutical Co., Ltd|
|Tokyo, Japan, 101-0031|