Gastroesophageal Reflux Disease Following Distal Gastrectomy with Billroth I Reconstruction
Conditions
Interventions
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
Sponsors
Kyosei Pharmaceutical Co., Ltd.
Kaigen Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female age 20 and over. 2) Patients having the primarily complaint of heartburn irregardless of the presence of esophagitis for whom 1 month to less than 6 months had elapsed following distal gastrectomy with Billroth I reconstruction. 3) Patients having symptoms of heartburn at a frequency of two or more days per week. 4) Patients having a score of 4 or more on the QUEST questionnaire. 5) Patients able to fill out diary cards as instructed. 6) Women participating in this study were required to have been determined to be postmenopausal, unable to become pregnant as a result of surgical measures, or using a form of birth control considered to be medically effective by the investigator(s). Consent was required to be obtained from women of child-bearing potential with respect to their continued use of a suitable form of birth control throughout the study period. 7) Patients from whom written informed consent was obtained.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elimination of GERD symptoms (heartburn, regurgitation, dysphagia and epigastric pain) | — |
Countries
Japan
Contacts
Public ContactKyosei Pharmaceutical Co., Ltd.
Kyosei Pharmaceutical Co., Ltd. Safety information
Outcome results
None listed