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

Myung-gui Choi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo and DA-9701; Drug: DA-9701 and placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01669772

DA-9701 trial

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

31 participants in 2 patient groups

DA-9701 and placebo

Other group

Description:

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.

Treatment:

Drug: DA-9701 and placebo

Placebo and DA-9701

Other group

Description:

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.

Treatment:

Drug: Placebo and DA-9701