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Sponsored by: |
Nihon Pharmaceutical Co., Ltd |
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Information provided by: | Nihon Pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT00742599 |
Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20 mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure).
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 |
---|---|---|
Patients Undergoing Gastric Endoscopy |
Drug: NPO-11 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-Blind, Parallel-Assignment , Placebo-Controlled Study) |
Estimated Enrollment: | 80 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
N: Active Comparator |
Drug: NPO-11
20 ml NPO-11
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P: Placebo Comparator |
Drug: Placebo
20 ml NPO-11(Placebo)
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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 visit medical institutions for treatment or follow-up of confirmed or suspected upper gastrointestinal disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study. The criteria (2) to (5) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.
Responsible Party: | Nihon Pharmaceutical Co., Ltd ( Yasumasa Ogawa ) |
Study ID Numbers: | NPO-11-01/C-01 |
Study First Received: | August 25, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00742599 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Stomach Diseases |
Stomach Diseases |