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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000772
Receipt No. R000000927
Scientific Title 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
Date of disclosure of the study information 2007/07/18
Last modified on 2009/01/20

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Basic information
Public title 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
Acronym 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
Scientific Title 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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition Gastroesophageal Reflux Disease Following Distal Gastrectomy with Billroth I Reconstruction
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was conducted for the purpose of comparing the efficacy of sodium alginate with that of mosapride citrate serving as a control in patients with gastroesophageal reflux disease following distal gastrectomy with Billroth I reconstruction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Elimination of GERD symptoms (heartburn, regurgitation, dysphagia and epigastric pain)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sodium alginate group: 20 mL of Alloid G administered for 8 weeks four times a day (q.i.d.) after meals and before bed.
Interventions/Control_2 Mosapride citrate group: 5 mg of Gasmotin tablet administered for 8 weeks three times a day (t.i.d.) after meals.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Makuuchi
Organization Tokai University School of Medicine
Division name Department of Surgery, Institute of Gastroenterology
Zip code
Address Bohseidai, Isehara-shi, Kanagawa, 259-1193 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kyosei Pharmaceutical Co., Ltd.
Organization Kyosei Pharmaceutical Co., Ltd.
Division name Safety information
Zip code
Address 1-25-18, Okusawa, Otaru-shi, Hokkaido, 047-0013 Japan
TEL
Homepage URL
Email

Sponsor
Institute Kyosei Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Kyosei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kaigen Co., Ltd.
Name of secondary funder(s) Kaigen Co., Ltd.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2008 Year 10 Month 01 Day
Date of closure to data entry
2009 Year 01 Month 01 Day
Date trial data considered complete
2009 Year 01 Month 01 Day
Date analysis concluded
2009 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 07 Month 18 Day
Last modified on
2009 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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