UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003716 |
|---|---|
| Receipt number | R000004494 |
| Scientific Title | Medicinal treatment on symptoms in patients with gastroesophageal reflux disease (GERD) refractory to PPIs. Multicenter, randomized, paralleled controlled study |
| Date of disclosure of the study information | 2010/06/07 |
| Last modified on | 2011/05/26 14:45:47 |
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Basic information
Public title
Medicinal treatment on symptoms in patients with gastroesophageal reflux disease (GERD) refractory to PPIs. Multicenter, randomized, paralleled controlled study
Acronym
Medicinal treatment for patients with PPIs-refractory GERD patients
Scientific Title
Medicinal treatment on symptoms in patients with gastroesophageal reflux disease (GERD) refractory to PPIs. Multicenter, randomized, paralleled controlled study
Scientific Title:Acronym
Medicinal treatment for patients with PPIs-refractory GERD patients
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease (GERD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate available pharmaceuticals on refractory GERD, we conducted a study to compare efficacy in relieving symptoms by between rikkunshito combined with a standard dose of rabeprazole (RPZ) and a double dose regimen of RPZ in a prospective randomized multi-center trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of acid reflux-related symptoms using Frequency scale for symptoms of GERD (FSSG)
Key secondary outcomes
Subgroup analysis for age, gender, BMI or endoscopic diagnose
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
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
Oral administration of rabeprazole (10mg) combined with rikkunshito
(7.5g) before meals for 28 days
Interventions/Control_2
Oral administration of rabeprazole (20mg)
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) GERD patients who were received a treatment of rabeprazole (10 mg once daily) for more than 4 weeks.
2) Patients who were defined as a score of more than 8 points estimated using the frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) after treatment with rabeprazole at standard dose (10 mg, once daily).
3) Patients who are able to administer orally
4) Patients who have signed consent to participate in this research
Key exclusion criteria
1) Patients with GERD which had C or D grade esophagitis diagnosed by endoscopic testing.
2) Patients with serious complications (e.g., hepatic, renal, cardiac, pulmonary, hematological, or metabolic diseases)
3) Patients with abscission of upper gastrointestinal tract
4) Patients who had peptic ulcer (excusing cicatrices) or tumor.
5) Patients with disorder in liver, gallbladder, or pancreas
6) Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation.
7) Patients who received drugs prohibited for concomitant use during the observation period
8) Patients who were received treatment of rabeprazole (20mg)
9) Patients with psychoneurosis
10) Patients with planning or during treatment of investigational drug
11) Patients with pregnant, considering pregnancy or lactation
12) Patients considered inappropriate by the study investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujimoto Kazuma |
Organization
Saga University Hospital
Division name
Department of Internal Medicine
Zip code
Address
5-1-1, Nabeshima, Saga
TEL
0952-34-2361
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujimoto Kazuma |
Organization
Saga University Hospital
Division name
Department of Internal Medicine
Zip code
Address
5-1-1, Nabeshima, Saga
TEL
0952-34-2361
Homepage URL
Sponsor or person
Institute
Department of Internal Medicine, Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka City University Hospital
Osaka Medical College Hospital
Gunma University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 06 | Month | 07 | 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
| 2008 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 04 | Day |
Last modified on
| 2011 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004494
