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Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men

This study has been completed.
Sponsor:
Information provided by:
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00740324
First received: August 21, 2008
Last updated: November 8, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 + scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The efficacy will be evaluated based on changes in the frequency of gastric peristalsis classification after the initial dose and the additional dose, and on the presence or absence of gastric peristalsis at each evaluation point.


Condition Intervention Phase
Healthy
 Drug: NPO-11
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men During Endoscopy

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Nihon Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • [Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration [ Time Frame: 7 ± 3 days after administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • [Efficacy] (Central evaluation by independent evaluator) (1) Change in the frequency of gastric peristalsis classification (2) Presence or absence of gastric peristalsis at each evaluation point [ Time Frame: each evaluation point ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: N Drug: NPO-11
NPO-11 after administration of NPO-11
Active Comparator: B Drug: NPO-11
20 mg butylscopolammonium bromide after administration of NPO-11
Active Comparator: G Drug: NPO-11
1 mg glucagons after administration of NPO-11

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy adult male volunteers who meet all the following criteria will be enrolled in the study. Subjects have to provide written informed consent for voluntary participation in the study.

  1. Volunteers who are in good health as confirmed by the investigator or subinvestigator
  2. Volunteers (age from 35 to less than 65 years old at the time of consent)

Exclusion Criteria:

Volunteers who meet any of the following criteria will be excluded from the study.

  1. Volunteers with any clinically significant symptoms, physical findings or laboratory values at screening visit which are considered unsuitable for participation in the study in the investigator's or subinvestigator's opinion
  2. Volunteers with a history of surgery in the upper gastrointestinal tract
  3. Volunteers with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
  4. Volunteers with a history of shock or hypersensitivity to scopolamine butylbromide, glucagon, lidocaine hydrochloride or heparin sodium
  5. Volunteers who are contraindicated for administration of scopolamine butylbromide or glucagon in the investigator's or subinvestigator's opinion based on health interview
  6. Volunteers who have been exposed to NPO-11
  7. Volunteers who have received other investigational drugs within four months before consent or who are participating in other clinical studies
  8. Volunteers otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740324

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Yasumasa Ogawa, Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00740324     History of Changes
Other Study ID Numbers: NPO-11-01/SE-02
Study First Received: August 21, 2008
Last Updated: November 8, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nihon Pharmaceutical Co., Ltd:
During
Endoscopy
Gastric
Peristalsis

Additional relevant MeSH terms:
Butylscopolammonium Bromide
Scopolamine
Glucagon
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013