Condition category
Digestive System
Date applied
28/06/2007
Date assigned
11/10/2007
Last edited
11/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kyoichi Adachi

ORCID ID

Contact details

Enya-cho 89-1
Izumo-shi
693-8501
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Rebamipide for NERD

Study hypothesis

Although half of the NERD patients who received Proton-Pump Inhibitors (PPI) for 4 weeks do not show their symptoms reduced, there is no standard therapy for these PPI-resistant patients. The esophageal mucosa of PPI-resistant NERD patients is hypersensitive to acid and histological damage may have occurred. Meanwhile, rebamipide is a gastro-protective agent and its antiinflammatory effect may improve histological damage of PPI-resistant NERD patients.

Ethics approval

Approval received from the ethics board of the Shimane University on the 29th April 2007.

Study design

Double-blind, randomized, placebo-controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Non-Erosive Reflux Disease (NERD)

Intervention

After being treated with lansoprazole 15 mg/day for 4 weeks, the NERD patients who do not show reduction in their symptoms (more than 6 points diagnosed by the QUEST questionnaire or below 50% improvement diagnosed by the Gastroesophageal Reflux Symptoms [GERS] score) will then be randomly allocated to the intervention or control group:

Intervention group: 100 mg rebamipide orally three times a day (t.i.d) for 4 weeks
Control group: Placebo tablet (t.i.d) for 4 weeks

Intervention type

Drug

Phase

Not Specified

Drug names

Rebamipide

Primary outcome measures

The subjective symptoms are assessed by the Japanese version QUEST and Gastrointestinal Symptom Rating Scale (GSRS). The assessment by GSRS is limited to upper gastrointestinal tract questions. These will be measured at baseline, 1 month after PPI therapy and 1 month after repamipide or placebo.

Secondary outcome measures

Number of patients who complete the study protocol.

Overall trial start date

01/06/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 20 and over
2. Heartburn (more than 6 points diagnosed by the Japanese version of questionnaire for the diagnosis of reflux disease [QUEST])
3. Signed a study-specific informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Endoscopic esophagitis
2. Gastric and duodenal ulcers, stomach cancer, or acute gastritis
3. Known hypersensitivity to rebamipide
4. Catastrophic complications
5. Pregnancy or desire to become pregnant
6. Judged inappropriate for this study by the physicians

Recruitment start date

01/06/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Japan

Trial participating centre

Enya-cho 89-1
Izumo-shi
693-8501
Japan

Sponsor information

Organisation

Shimane University, Second Department of Internal Medicine (Japan)

Sponsor details

Enya-cho 89-1
Izumo-shi
693-8501
Japan

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Shimane University Hospital (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes