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OpenTrials
Completed

NCT Number: NCT01719575

Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers

The purpose of this study is to compare the effects of Motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.

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Key information

Conditions

Healthy Female and Male

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the Catholic university of korea college of Medicine, Seoul St.Mary's hospital

Banpo-dong, Seocho-gu, Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no gastrointestinal symptoms
  • no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy
  • written informed consent

Exclusion criteria

  • pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception
  • history of abdominal surgery that may influence gastrointestinal motility
  • gastrointestinal hemorrhage, mechanical ileus, enterobrosis
  • irritable bowel syndrome, inflammatory bowel disease
  • severe disturbance of liver, kidney, heart,lung,blood and endocrine
  • psychoneurosis, alcoholism, drug dependence
  • medications that may alter evaluation of Motilitone including antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI, anticolines, erythromycin, antidepressive agents withing 2weeks

Treatment and study plan

Motilitone

Drug

Placebo

Drug

Primary outcomes

  1. gastric fuction of Motilitone

    Time frame: 3 weeks

    gastric emptying time on day 4 by scintigraphic imaging

  2. gastric function of Motilitone

    Time frame: 3 weeks

    fasting and postprandial gastric volume on day 7 by single photon emission computed tomography

Secondary outcomes

  1. adverse events of Motilitone

    Time frame: 3 weeks

  2. small bowel function of Motilitone

    Time frame: 3 weeks

    small bowel transit time on day 4 by scintigraphic transit measurement

  3. Colon function of Motilitone

    Time frame: 3 weeks

    colon transit time on day 4 and 7 by KUB

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers

Acronym: DA-9701

Important dates

Study start
2012
Primary completion
2012
First posted
Nov 1, 2012
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.