UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000000772
Receipt number	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 11:05:44

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Gastroesophageal Reflux Disease Following Distal Gastrectomy with Billroth I Reconstruction

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

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

Dynamic allocation

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method

Intervention

No. of arms

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 or person

Institute

Kyosei Pharmaceutical Co., Ltd.

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000927

1st name
Middle name
Last name	Kyosei Pharmaceutical Co., Ltd.