Examination of large intestine contraction patterns by mosapride citrate for irritable bowel syndrome (IBS, constipation type) using a capsule endoscope

UMIN ID: UMIN000001377

Registered date:17/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Irritable bowel syndrome (constipation type)
• Date of first enrollment: 2008/09/01
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Mosapride citrate 15 mg taken once daily in the morning after meal. Administration period is 4 to 5 weeks. Capsule endoscopy conducted before administration and after end of administration period.

Outcome(s)

• Primary Outcome: Symptoms of IBS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients who have taken mosapride citrate or other gastrointestinal function improving drug within 1 week before enrollment in prior treatment. 2) Patients with serious hepatic or renal impairment. 3) Patients taking a gastrointestinal function improving drug other than mosapride citrate concomitantly. 4) Patients with previous gastrointestinal surgery. 5) Patients with long-term use of nonsteroidal antiphlogistic analgetics. 6) Patients undergoing radiation therapy. 7) Patients taking calcium antagonists. 8) Patients taking iron or sucralfate preparations who cannot stop before start of the study. 9) Patients with ulcers, hemorrhage, gastrointestinal stenosis, obstruction, etc. 10) Patients with Crohn's disease. 11) Patients with an embedded electronic medical device such as a cardiac pacemaker. 12) Patients with dysphagia. 13) Patients with serious gastrointestinal diverticular disease. 14) Patients complicated by diabetes. 15) Patients with a history of allergy to mosapride citrate. 16) Patients whom the attending physician judges to be an inappropriate subject.

Related Information

• Primary Sponsor: Nagoya University Graduate School of Medicine Department of Gastroenterology
• Source(s) of Monetary Support: None