Randomization of Sodium Alginate and Mosapride Citrate for Patients with Gastroesophageal Reflux Disease (GERD) Following Distal Gastrectomy with Billroth I Reconstruction - A Multicenter Comparative Study

UMIN ID: UMIN000000772

Registered date:18/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastroesophageal Reflux Disease Following Distal Gastrectomy with Billroth I Reconstruction
• Date of first enrollment: 2006/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Sodium alginate group: 20 mL of Alloid G administered for 8 weeks four times a day (q.i.d.) after meals and before bed.
Mosapride citrate group: 5 mg of Gasmotin tablet administered for 8 weeks three times a day (t.i.d.) after meals.

Outcome(s)

• Primary Outcome: Elimination of GERD symptoms (heartburn, regurgitation, dysphagia and epigastric pain)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients for whom identification of subjective symptoms was difficult due to being caused by other diseases. 2) Patients with postoperative complications that may affect the evaluation of this clinical study. 3) Patients with gastrointestinal bleeding, mechanical ileus or gastrointestinal perforation. 4) Patients with liver or kidney disease. 5) Patients requiring continuous administration of the following drugs: drugs having anticholinergic action such as atropine sulfate or scopolamine butylbromide, antacids, oral protease inhibitors, H2 receptor antagonists such as cimetidine or ranitidine, PPI such as omeprazole, mucous membrane protectors other than sodium alginate, gastrointestinal motility ameliorants other than mosapride citrate, herbal medicines having action that promotes gastrointestinal motility such as Daikenchu-to or Rikkunshi-to, and drugs known to have a drug-interacting action with sodium alginate or mosapride citrate. 6) Patients for which the investigational products used in this study or excipients thereof are contra-indicated. (including patients clearly allergic or suspected of being allergic to the investigational products used in this study or excipients thereof) 7) Patients who participated in a clinical study within three months prior to this study. 8) Patients having a history or are currently suffering from alcohol or drug abuse. 9) Patients refusing to sign the consent form or unable to give an acceptable informed consent due to mental deficiency or language problems. 10) Patients suspected of or confirmed to have demonstrated poor compliance (strict observance of taking medication) during the treatment period. 11) Pregnant or breast-feeding women. 12) Patients having been judged to be ineligible to participate in this study by the investigator(s) for any other reason.

Related Information

• Primary Sponsor: Kyosei Pharmaceutical Co., Ltd.
• Secondary Sponsor: Kaigen Co., Ltd.
• Source(s) of Monetary Support: Kyosei Pharmaceutical Co., Ltd.,Kaigen Co., Ltd.