Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
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|ClinicalTrials.gov Identifier: NCT01411189|
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : June 29, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Colon Nos Polypectomy Tubular Adenoma Gastric Adenoma||Drug: Menthol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
20 mL NPO-11
20 mL NPO-11 in prefilled syringe
- 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 (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 ]
- Difficulty level of the therapeutic procedure [ 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): NCT01411189
|Nihon Pharmaceutical Co., Ltd|
|Tokyo, Japan, 101-0031|