Adhesion of ecabet sodium in the form of enteric coated capsule to the surface of small intestine.

UMIN ID: UMIN000001801

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 2009/04/01
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Granule form of ecabet sodium
Enteric coated capsule form of ecabet sodium

Outcome(s)

• Primary Outcome: To compare the adhesive ability of ecabet sodium in the form of enteric coated capsule with that in the form of conventional granules to small intestine

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Organic disease(Reflux esophagitis, Peptic ulcer disease, Erosive gastritis) 2. Past history of GI resection surgery other than appendectomy. 3. Intestinal lesions such as Crohn's disease, Behcet disease. 4. Patients with pace maker or with other electric device in the body 5. NSAIDs user, Patients with severe stress conditions 6. Organic disease in brain, Depression and Schizophrenia 7. Alcoholics and Drug dependence 8. Hyperthyroidism 9. Severe heart, liver and kidney diseases or infectious diseases 10. Drug allergy for ecabet sodium 11. Expectant mother, Breast feeding mother 12. Drug (anti-secretory drugs, prokinetics, antacid, anti-cholinergic agents, tranquilizer, anti-depressant)users within a week before the entry. 13. Subjects recognized as not suitable to the test by doctor.

Related Information

• Primary Sponsor: Keio University School of Medicine
• Source(s) of Monetary Support: Keio University School of Medicine