Phase III 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 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 | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: Menthol Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
- 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. 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 ]
- One-piece resection rate with tumor-free margin [ 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: | 85 |
| 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 |
|---|---|
|
Active Comparator: Menthol
20 ml NPO-11
|
Drug: Menthol
20 mL NPO-11 in a prefilled plastic syringe
|
|
Placebo Comparator: Placebo
20 ml NPO-11(Placebo)
|
Drug: Placebo
The placebo is included same additives as active comparator.
|
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 (EMR or ESD) and meet the criteria (1)-(4) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study. The criteria (2) and (3) will be confirmed by the endoscopic observation just before starting the intended treatment.
- Patients with an early gastric cancer located in the lower third of the stomach, who require therapeutic upper gastrointestinal endoscopy (EMR or ESD) (except for those with an intended treatment by using a scope of <9 mm in diameter)
- Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in size, no ulcer finding
- Patients with a single intended lesion for the treatment
- 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) to (5) 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 a lesion extended to the pyloric ring
- 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
- Patients with contraindications to glucagon
- Patients with contraindications to benzodiazepines, pethidine hydrochloride, and epinephrine
- 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: | NCT01411176 History of Changes |
| Other Study ID Numbers: | NPO-11-02/C-02 |
| Study First Received: | August 2, 2011 |
| Last Updated: | June 27, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Nihon Pharmaceutical Co., Ltd:
|
upper gastrointestinal endoscopy suspected gastric cancer |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Stomach Diseases Menthol Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013