Therapeutic study of the proton- pump inhibitors resistant patients with Non-Erosive Reflux Disease

ISRCTN	ISRCTN82345975
DOI	https://doi.org/10.1186/ISRCTN82345975
Protocol serial number	N/A
Sponsor	Shimane University, Second Department of Internal Medicine (Japan)
Funder	Shimane University Hospital (Japan)

Submission date: 28/06/2007
Registration date: 11/10/2007
Last edited: 19/07/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kyoichi Adachi
Scientific

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

Study information

Primary study design	Interventional
Study design	Double-blind, randomized, placebo-controlled study.
Secondary study design	Randomised controlled trial
Scientific title	Therapeutic study of the proton- pump inhibitors resistant patients with Non-Erosive Reflux Disease
Study acronym	Rebamipide for NERD
Study objectives	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(s)	Approval received from the ethics board of the Shimane University on the 29th April 2007.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Rebamipide
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Number of patients who complete the study protocol.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Total final enrolment	149
Key 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
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Japan

Study participating centre

Enya-cho 89-1

Izumo-shi
693-8501
Japan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article			19/07/2021	Yes	No

Editorial Notes

19/07/2021: Publication reference and total final enrolment added.