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Completed

NCT Number: NCT01669772

Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Volunteers

DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These plants have been used in oriental traditional medicine for the treatment of gastrointestinal maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in functional dyspepsia patients and proved to have comparable safety and efficacy. However, its' exact effect on the gastrointestinal motility has not been completely elucidated. This study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul St Mary's hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults of either sex, at least 20 years of age
  • Having no abdominal discomfort or pain
  • No diseases diagnosed by screening gastroduodenoscopy
  • Having given voluntary written consent

Exclusion criteria

  • Currently participating or having participated in another drug trial within four weeks of trial start.
  • Women of childbearing age who are either pregnant, breast-feeding or not under proper contraceptive methods.
  • A history of surgery which may affect gastrointestinal motility.
  • Subjects with gastrointestinal bleeding, mechanical obstruction or perforation.
  • Subjects with irritable bowel syndrome or inflammatory bowel disease.
  • Subjects with serious conditions involving the liver, kidneys, heart, lung or endocrinology system.
  • Psychiatric disease patients, substance abuse subjects such as alcohol or drugs.
  • Subjects who have taken drugs that may affect the study outcome such as antibiotics, corticosteroids or NSAIDS within 1 month or motility agents, H2 receptor blockers, proton pump inhibitors, anticholinergics, erythromycin or antipsychotics within 2 weeks.
  • Other reasons that the investigator considers valid.

Treatment and study plan

DA-9701 and placebo

Drug

Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo.

Other names: DA-9701(motilitone)

Placebo and DA-9701

Drug

Administer placebo 1 tablet t.i.d for 1 week. After 1 week of washout, crossover to 30mg of DA-9701 t.i.d. for 1 week.

Other names: DA-9701(motilitone)

Primary outcomes

  1. Study the effects of DA-9701 on GI motility in healthy adult volunteers

    Time frame: 3weeks

    Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers

Secondary outcomes

  1. Examine the effects of DA-9701 by Scintigraphic transit measurement

    Time frame: 3weeks

    Examine the effects of DA-9701 by Scintigraphic transit measurement

  2. Examine the effects of DA-9701 by EGG/Drink test

    Time frame: 3weeks

    Examine the effects of DA-9701 by EGG/Drink test

  3. Examine the effects of DA-9701 by SPECT

    Time frame: 3weeks

    Examine the effects of DA-9701 by SPECT

Sponsors and collaborators

Lead sponsor

Myung-gui Choi

Other

Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

Registry information

Official study title

Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Males and Female Subjects

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 21, 2012
Registry last updated
Jul 3, 2014

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.

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