Efficacy of Motilitone on Gastric Accommodation in Healthy Adult Patients: Evaluation Using MRI Method

Last updated: March 18, 2014
Sponsor: Samsung Medical Center
Overall Status: Completed

Phase

N/A

Condition

Colic

Heartburn

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT02091635
Motilitone
  • Ages 20-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of a specific structural cause. Improving gastric accommodation and prokinetic effect seem to be an attractive physiological target in patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in December 2011 in Korea for treating patients with FD. The current study aims to evaluate effects of motilitone on gastric accommodation and emptying after a meal in a group of healthy volunteers using three-dimensional gastric volume measurements by magnetic resonance imaging (MRI). Healthy volunteers are randomly allocated to receive either motilitone or placebo in a double blinded manner. After 5 days of treatment, subjects undergo gastric MRI. The primary endpoint is gastric accommodation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy volunteers between 20 and 70 years of age without upper abdominal pain ordiscomfort and a structural abnormality on upper gastrointestinal (GI) endoscopyperformed within the preceding 6 months were eligible for the trial.

Exclusion

Exclusion Criteria:

  • Patients were excluded if they met any of the following criteria:

  1. any functional GI disease or previous abdominal surgery

  2. diabetes mellitus under insulin or oral anti-hyperglycemic agent treatment

  3. significant cardiopulmonary diseases or any malignancies

  4. significant renal (serum creatinine level ≥ 1.5 × the upper normal limit) orliver disease (serum aspartate aminotransferase and alanine aminotransferaselevels ≥ 2.5 × the upper normal limits

  5. taking medications that may alter gastric function within 2 weeks prior to thestart of the study

  6. pregnancy or lactation

  7. females with inadequate contraception during the study period

  8. contraindications to MRI (e.g., cardiac pacemaker or metallic aneurysm clip)

  9. allergic history to motilitone

  10. other conditions likely to interfere with study procedures, as judged by theinvestigator

Study Design

Total Participants: 40
Study Start date:
August 01, 2013
Estimated Completion Date:
December 31, 2013

Connect with a study center

  • Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

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