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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:
ClinicalTrials.gov Identifier:
NCT00740324
First Posted: August 22, 2008
Last Update Posted: November 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nihon Pharmaceutical Co., Ltd
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740324


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

Responsible Party: Yasumasa Ogawa, Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00740324     History of Changes
Other Study ID Numbers: NPO-11-01/SE-02
First Submitted: August 21, 2008
First Posted: August 22, 2008
Last Update Posted: November 9, 2010
Last Verified: November 2010

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

Additional relevant MeSH terms:
Glucagon
Glucagon-Like Peptide 1
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics