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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669772
• Other study ID #: DA-9701 trial
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 12, 2012
• Last updated: July 2, 2014
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul St Mary's hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Myung-gui Choi	Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the effects of DA-9701 on GI motility in healthy adult volunteers	Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers	3weeks	Yes
Secondary	Examine the effects of DA-9701 by Scintigraphic transit measurement	Examine the effects of DA-9701 by Scintigraphic transit measurement	3weeks	No
Secondary	Examine the effects of DA-9701 by EGG/Drink test	Examine the effects of DA-9701 by EGG/Drink test	3weeks	No
Secondary	Examine the effects of DA-9701 by SPECT	Examine the effects of DA-9701 by SPECT	3weeks	No