Clinical Trial: Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

Brief 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.


Detailed Summary:
Sponsor: Nihon Pharmaceutical Co., Ltd

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Nihon Pharmaceutical Co., Ltd

Dates:
Date Received: August 3, 2011
Date Started: September 2011
Date Completion:
Last Updated: June 27, 2012
Last Verified: June 2012