UMIN-CTR Clinical Trial

Public title

Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions

Acronym

Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions

Scientific Title

Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions

Scientific Title:Acronym

Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions

Region

Japan

Condition

nonsteroidal antiinflammatory drug induced small intestinal lesions

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the influence of differences in the type or dose of proton pump inhibitors (PPI) on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

Number of mucosal breaks (erosion, ulcer) in the small intestine on capsule endoscopy at the completion of administration

Key secondary outcomes

Number of sites of redness in the small intestine on capsule endoscopy at the completion of administration, Lewis score, fecal Calprotectin, serum DAO activity, and adverse effects

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Diclofenac at 75 mg/day was orally administered after every meal (3 times a day), and vonoprazan at 20 mg after breakfast (once a day) for 14 days

Interventions/Control_2

Diclofenac at 75 mg/day was orally administered after every meal (3 times a day), and rabeprazole at 5 mg after breakfast (once a day) for 14 days

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Patients who are not being orally treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (2) Those who are not being orally treated with PPI, H2 receptor antagonists, mucoprotective drugs, or prokinetics (3) Those from whom written informed consent regarding participation in this study was obtained.

Key exclusion criteria

(1)a history of allergy to diclofenac, rabeprazole, vonoprazan (2)a history of peptic ulcers or gastrointestinal bleeding, ulcerative colitis, Crohn' s disease (3)a history of gastrointestinal surgery other than appendectomy (4)a history of intestinal obstruction or suspected gastrointestinal obstruction on other tests (5)significant hepatic, renal, heart, or respiratory disease (6)Pregnant women, those who may become pregnant during the study period, and lactating women (7)a lack of consent for the surgery required if the capsule endoscope was retained within the body (8)determination by the investigator (at his/her discretion) that the subject was ineligible for participation in the study for any other reason

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Higuchi Kazuhide

Organization

Osaka Medical College

Division name

Second Department of Internal Medicine

Zip code

Address

2 7 Daigakumachi Takatsuki Osaka Japan

TEL

072-683-1221

Email

higuchi@osaka-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Yuichi Kojima

Organization

Osaka Medical College

Division name

Endoscopy Center

Zip code

Address

2 7 Daigakumachi Takatsuki Osaka Japan

TEL

072-683-1221

Homepage URL

Email

in2134@osaka-med.ac.jp

Institute

Second Department of Internal Medicine, Osaka Medical College

Institute

Department

Personal name

Organization

Osaka Medical College

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪医科大学附属病院

Date of disclosure of the study information

2016

Year

11

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

terminate this trial to change the protocol

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

Recruitment status

Terminated

Date of protocol fixation

2016

Year

11

Month

07

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

11

Month

14

Day

Last modified on

2017

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028519