Therapeutic study of the proton- pump inhibitors resistant patients with Non-Erosive Reflux Disease
| ISRCTN | ISRCTN82345975 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82345975 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Kyoichi Adachi
Scientific
Scientific
Enya-cho 89-1
Izumo-shi
693-8501
Japan
Study information
| Study design | Double-blind, randomized, placebo-controlled study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Therapeutic study of the proton- pump inhibitors resistant patients with Non-Erosive Reflux Disease |
| Study 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(s) | Approval received from the ethics board of the Shimane University on the 29th April 2007. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rebamipide |
| Primary outcome measure | 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 study start date | 01/06/2007 |
| Overall study end date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 149 |
| 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 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
Study participating centre
Enya-cho 89-1
Izumo-shi
693-8501
Japan
693-8501
Japan
Sponsor information
Shimane University, Second Department of Internal Medicine (Japan)
University/education
University/education
Enya-cho 89-1
Izumo-shi
693-8501
Japan
"ROR" |
https://ror.org/01jaaym28 |
|---|
Funders
Funder type
University/education
Shimane University Hospital (Japan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
