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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: DA-9701 and placebo; Drug: Placebo and DA-9701

• Registration Number: NCT01669772
• Lead Sponsor: Myung-gui Choi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-21
• Primary Completion: 2013-02
• Study Completion: 2013-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DA-9701 and placebo	DA-9701 and placebo	Administer DA-9701 for 1week and assess the study outcomes. After 1 week of washout period, administer placebo for 1week and assess the outcomes again.
Placebo and DA-9701	Placebo and DA-9701	Administer placebo for 1 week and study the outcome parameters. After 1 week of washout, administer DA-9701 for 1 week and assess the outcome parameters again.

Primary Outcome Measures

Name	Time	Method
Study the effects of DA-9701 on GI motility in healthy adult volunteers	3weeks	Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers

Secondary Outcome Measures

Name	Time	Method
Examine the effects of DA-9701 by Scintigraphic transit measurement	3weeks	Examine the effects of DA-9701 by Scintigraphic transit measurement
Examine the effects of DA-9701 by EGG/Drink test	3weeks	Examine the effects of DA-9701 by EGG/Drink test
Examine the effects of DA-9701 by SPECT	3weeks	Examine the effects of DA-9701 by SPECT

Trial Locations

Locations (1)

Seoul St Mary's hospital; 🇰🇷 Seoul, Korea, Republic of