Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastric Cancer Colon Nos Polypectomy Tubular Adenoma Gastric Adenoma |
Drug: Menthol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy |
- 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.
- 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 ]
| Enrollment: | 33 |
| Study Start Date: | September 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Menthol
20 mL NPO-11
|
Drug: Menthol
20 mL NPO-11 in prefilled syringe
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
- Patients who require therapeutic upper gastrointestinal endoscopy (polypectomy, endoscopic hemostasis, PEG, EMR and ESD)
- 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)
- Patients with a gastric adenoma (≤2 cm in size, no ulcer finding, EMR or ESD)
- Patients with an a single intended lesion for the treatment
- Patients without experience of PEG tube placement in case of PEG tube placement
- 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.
- Patients with a history of surgery to the upper gastrointestinal tract
- Patients who require emergency endoscopy
- Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
- Patients who require emergency endoscopic treatment except for the intended lesion
- Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
- Patients with pacemaker
- Patients with known bleeding tendency or Patients with difficulty of antithrombogenic agents withdrawal
- Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
- Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
- Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
- Patients otherwise ineligible for participation in the study in the investigator's opinion
Contacts and Locations More Information
No publications provided
| Responsible Party: | Nihon Pharmaceutical Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT01411189 History of Changes |
| Other Study ID Numbers: | NPO-11-02/S-02 |
| Study First Received: | August 3, 2011 |
| Last Updated: | June 27, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Nihon Pharmaceutical Co., Ltd:
|
therapeutic upper gastrointestinal endoscopy percutaneous endoscopic gastrostomy endoscopic mucosal resection endoscopic submucosal dissection |
PEG EMR ESD endoscopic hemostasis |
Additional relevant MeSH terms:
|
Adenoma Stomach Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Menthol Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013