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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033984 |
Receipt No. | R000038751 |
Scientific Title | Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study |
Date of disclosure of the study information | 2018/09/01 |
Last modified on | 2018/09/01 |
Basic information | ||
Public title | Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study | |
Acronym | Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury | |
Scientific Title | Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study | |
Scientific Title:Acronym | Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury | |
Region |
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Condition | ||
Condition | LDA-induced small intestinal mucosal injury | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this clinical study was to investigate how high-dose ES affects LDA-induced small intestinal mucosal injury. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Severity of small intestinal mucosal injury using small bowel capsule endoscopy |
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 | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | The subjects in group A received LDA (100 mg) once daily. | |
Interventions/Control_2 | The subjects in group B received LDA and 4.0 g of ES (1.0 g four times daily). | |
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 | 1) freely provided informed consent on the basis of their full understanding of the study protocol, and 2) had no history of medication use during the month before enrolment in the study | |||
Key exclusion criteria | 1) history of peptic ulcer or gastrointestinal bleeding; 2) significant hepatic, renal, heart, or respiratory disease; 3) history of gastrointestinal surgery other than appendectomy; 4) use of oral histamine H2-receptor antagonists, gastrointestinal kinetic agents, and gastric mucoprotective drugs within 2 weeks before the study; 5) use of oral non-steroidal anti-inflammatory drugs (NSAIDs), steroids, anticholinergic drugs, anticancer drugs, or antithrombotic drugs within 4 weeks prior; 6) alcohol or chemical dependency; 7) history of gastrointestinal obstruction; 8) refusal to consent to the surgery that would be required if the capsule endoscope was retained in the body; and 9) determination by the investigator, at his/her discretion, that a subject was ineligible for participation in the study for any reason. | |||
Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka medical college | ||||||
Division name | Second department of internal medicine | ||||||
Zip code | |||||||
Address | 2-7, Daigaku-machi, Takatsuki | ||||||
TEL | 072-683-1221 | ||||||
higuchi@osaka-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka medical college | ||||||
Division name | Second department of internal medicine | ||||||
Zip code | |||||||
Address | 2-7, Daigaku-machi, Takatsuki | ||||||
TEL | 072-683-1221 | ||||||
Homepage URL | |||||||
clash_kaz@yathoo.co.jp |
Sponsor | |
Institute | Osaka medical college |
Institute | |
Department |
Funding Source | |
Organization | Osaka medical college |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 | 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 |
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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/ctr_e/ctr_view.cgi?recptno=R000038751 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |