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UMIN-CTR Clinical Trial |
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Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000011797 |
Receipt No. | R000013661 |
Scientific Title | A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease |
Date of disclosure of the study information | 2013/09/20 |
Last modified on | 2013/09/18 |
Basic information | ||
Public title | A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease | |
Acronym | A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease | |
Scientific Title | A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease | |
Scientific Title:Acronym | A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease | |
Region |
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Condition | ||
Condition | Gastroesophageal reflux disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of the study is to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with GERD |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 1)Change rate of average numerical rating scale (NRS) of sleep quality between a pre-dose and a post-dose of 2-4 weeks after administration
2)Fluctuation of scores in sleep dysfunction questionnaires between a pre-dose and a post-dose of 2-4 weeks after administration |
Key secondary outcomes | Fluctuation of scores in F-scale questionnaires between a pre-dose and a post-dose of 2-4 weeks after administration
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In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 10 mg of sodium rabeprazole administered orally once daily from 2 to 4 weeks | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | A patient is eligible for the study if all of the following criteria are met:
1) Age 20 years or older 2) Patients with more than 8 scores in the Frequency scale for Symptoms of GERD (F-scale questionnaires) 3) Patient with at least 2 weeks washout period from the previous treatment by Proton pump inhibitors and Histamine H2-receptor antagonists |
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Key exclusion criteria | A patient is excluded from the study if any of the following criteria are met:
1) Patients with a history of hypersensitivity to any ingredients of sodium rabeprazole 2) Patients taking atazanavir sulfate or rilpivirine hydrochloride 3) Patients with serious hepatic function disorder 4) Elderly patients (Age 80 years and older) 5) Patients who were judged to be inappropriate for participation in this study by the investigator |
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Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Heiwadai clinic | ||||||
Division name | Surgery | ||||||
Zip code | |||||||
Address | 4-26-8,Heiwadai,Nerima-ku,Tokyo,Japan | ||||||
TEL | 03-5922-1241 | ||||||
bk2m-cbi@asahi-net.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Heiwadai clinic | ||||||
Division name | Surgery | ||||||
Zip code | |||||||
Address | 4-26-8,Heiwadai,Nerima-ku,Tokyo,Japan | ||||||
TEL | 03-5922-1241 | ||||||
Homepage URL | |||||||
bk2m-cbi@asahi-net.or.jp |
Sponsor | |
Institute | Heiwadai clinic |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | The results was presented in the 85th meeting of Japan gastroenterological endoscopy society. |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013661 |