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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01411189
First received: August 3, 2011
Last updated: June 27, 2012
Last verified: June 2012

August 3, 2011
June 27, 2012
September 2011
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01411189 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Cancer
  • Colon Nos Polypectomy Tubular Adenoma
  • Gastric Adenoma
Drug: Menthol
20 mL NPO-11 in prefilled syringe
Menthol
20 mL NPO-11
Intervention: Drug: Menthol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inpatients or outpatients of either sex who require therapeutic upper gastrointestinal endoscopy and meet criteria (1), (4), (6) and one from (2), (3) or (5) in the study. Patients have to provide written informed consent for voluntary participation in the study. The criteria (2) to (4) will be confirmed by the endoscopic observation just before starting the intended treatment.

  1. Patients who require therapeutic upper gastrointestinal endoscopy (polypectomy, endoscopic hemostasis, PEG, EMR and ESD)
  2. Patients with a differentiated-type intramucosal gastric cancer located in the upper or middle third of the stomach (≤2 cm in size, no ulcer finding, EMR or ESD)
  3. Patients with a gastric adenoma (≤2 cm in size, no ulcer finding, EMR or ESD)
  4. Patients with an a single intended lesion for the treatment
  5. Patients without experience of PEG tube placement in case of PEG tube placement
  6. Patients who are older than 20 years at the time of consent

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study beforehand. The criteria (3) and (4) will be confirmed by the endoscopic observation just before starting the intended treatment.

  1. Patients with a history of surgery to the upper gastrointestinal tract
  2. Patients who require emergency endoscopy
  3. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
  4. Patients who require emergency endoscopic treatment except for the intended lesion
  5. Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
  6. Patients with pacemaker
  7. Patients with known bleeding tendency or Patients with difficulty of antithrombogenic agents withdrawal
  8. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
  9. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
  10. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
  11. Patients otherwise ineligible for participation in the study in the investigator's opinion
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01411189
NPO-11-02/S-02
No
Nihon Pharmaceutical Co., Ltd
Nihon Pharmaceutical Co., Ltd
Not Provided
Not Provided
Nihon Pharmaceutical Co., Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP