UMIN-CTR Clinical Trial
| Recruitment status | Open public recruiting |
| Unique ID issued by UMIN | UMIN000012363 |
| Receipt No. | R000014453 |
| Scientific Title | Study of the effectiveness of mosapride for GERD patients with sleep disorders |
| Date of disclosure of the study information | 2013/11/20 |
| Last modified on | 2020/05/26 (Ver. 4) |
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| Basic information | ||
| Public title | Study of the effectiveness of mosapride for GERD patients with sleep disorders | |
| Acronym | Study of the effectiveness of mosapride for GERD patients with sleep disorders | |
| Scientific Title | Study of the effectiveness of mosapride for GERD patients with sleep disorders | |
| Scientific Title:Acronym | Study of the effectiveness of mosapride for GERD patients with sleep disorders | |
| 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 | For gastroesophageal reflux disease patients with sleep disorders despite the administration of a proton pump inhibitor, to the obvious add-on medication of mosapride whether or not effective in improving sleep disorders. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Pre-dose, two weeks after dosing, four weeks after dosing, have them listed Japanese translation of the Quality of Life in Reflux and Dyspepsia (QOLRAD-J), Epworth Sleepness Scale (ESS), Pittsburgh Sleep Quality Index in (PSQI), respectively to evaluate. |
| Key secondary outcomes | |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | Individual |
| Blinding | Double blind -all involved are blinded |
| Control | Placebo |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | Institution is not considered as adjustment factor. |
| Blocking | |
| Concealment | No need to know |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | Proton pump inhibitor of the standard dose (+)
mosapride(15 mg / day for 4 weeks) |
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| Interventions/Control_2 | Proton pump inhibitor of the standard dose(+)
Placebo(+) |
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| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | In GERD patients with sleeping disorders, who Proton pump inhibitor of standard doses of (PPI) during treatment | |||
| Key exclusion criteria | Example that started the oral sleep-inducing agent within two weeks.
Patients with serious underlying disease that affect sleep. Examples are allergic to mosapride. Examples of oral administration of the drug combination and attention mosapride. Examples of oral medicine in the related to gastrointestinal motor function. Patients with psychiatric disorders. Examples of surgical procedures after the gastroesophageal. Example pregnant or nursing. Example not be obtained consent. Example the attending physician is deemed inappropriate. |
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| Target sample size | 100 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Shimane University School of Medicine | ||||||
| Division name | Department of Gastroenterology | ||||||
| Zip code | 693-0021 | ||||||
| Address | Izumo, Shimane Prefecture Enya-cho 89-1 | ||||||
| TEL | 0853-23-2111 | ||||||
| okimotoeiko@outlook.com | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Shimane University School of Medicine | ||||||
| Division name | Department of Gastroenterolog | ||||||
| Zip code | 693-0021 | ||||||
| Address | Izumo, Shimane Prefecture Enya-cho 89-1 | ||||||
| TEL | 0853-20-2190 | ||||||
| Homepage URL | |||||||
| okimotoeiko@outlook.com | |||||||
| Sponsor | |
| Institute | Department of Gastroenterology , Shimane University School of Medicine |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Department of Gastroenterology , Shimane University School of Medicine |
| 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 | Shimane University School of Medicine Clinical Research Center |
| Address | Izumo, Shimane Prefecture Enya-cho 89-1 |
| Tel | :0853-20-2492 |
| tiken@med.shimane-u.ac.jp | |
| 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 | 島根大学医学部付属病院（島根県）、出雲市立総合医療センター（島根県）、益田地域医療センター医師会病院（島根県）、松江市立病院（島根県）、松江赤十字病院（島根県）、はまもと内科クリニック（島根県） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | URL releasing protocol |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | URL releasing protocol | ||||||
| Number of participants that the trial has enrolled | 0 | ||||||
| Results | Discontinuation of the test |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Discontinuation of the test |
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| Participant flow | Discontinuation of the test |
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| Adverse events | Discontinuation of the test |
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| Outcome measures | Discontinuation of the test |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Open public recruiting | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded |
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| 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/icdr_e/ctr_view.cgi?recptno=R000014453 |
