UMIN-CTR Clinical Trial

Public title

Incidence of esophagitis, peptic ulcers and small intestinal mucosal lesions induced by loxoprofen, etodolac and celecoxib in healthy volunteers: a prospective randomized comparative trial

Acronym

Clinical trial for the incidence of gastrointestinal lesions by selective COX-2 inhibitor

Scientific Title

Incidence of esophagitis, peptic ulcers and small intestinal mucosal lesions induced by loxoprofen, etodolac and celecoxib in healthy volunteers: a prospective randomized comparative trial

Scientific Title:Acronym

Clinical trial for the incidence of gastrointestinal lesions by selective COX-2 inhibitor

Region

Japan

Condition

NSAID induced gastrointestinal mucosal lesions

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the esophagitis, peptic ulcers and small intestinal mucosal lesions induced by loxoprofen, etodolac and celecoxib, in healthy volunteers

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The numbers of small intestinal mucosal breaks evaluated by capsule endoscopy

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Famotidine 20 mg/day b.i.d. and loxoprofen 180 mg/day t.i.d for 2 weeks by oral administration

Interventions/Control_2

Famotidine 20 mg/day b.i.d. and etodolac 400 mg/day b.i.d for 2 weeks by oral administration

Interventions/Control_3

Famotidine 20 mg/day b.i.d. and celecoxib 200 mg/day b.i.d for 2 weeks by oral administration

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) Healthy adults who are 20 years or older, and less than 80 years of age at the time of obtaining informed consent
2) Subjects from whom fully informed written consent based on their full understanding and their own voluntary will was obtained at the commencement of this study

Key exclusion criteria

1) Subjects who have active peptic ulcer or gastrointestinal bleeding and need endoscopic treatment immediately
2) Subjects with significant hepatic disease, renal disease, heart disease or respiratory disease
3) Subjects with a history of gastrointestinal surgery other than appendectomy
4) Subjects orally taking or planning to orally take drug other than loxoprofen, etodolac, celecoxib or famotidine
5) Subjects with alcohol or chemical dependencies
6) Subjects with a history of intestinal obstruction, or person with suspected gastrointestinal
obstruction on other tests
7)Subjects who cannot agree that surgery may be required if capsule endoscope retained in the body
8) Subjects whom otherwise the investigator determined ineligible as the subject

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhide Higuchi

Organization

Osaka Medical College

Division name

Second Department of Internal Medicine

Zip code

Address

2-7 Daigakumachi Takatsuki Osaka 569-8686 Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Eiji Umegaki

Organization

Osaka Medical College

Division name

Second Department of Internal Medicine

Zip code

Address

2-7 Daigakumachi Takatsuki Osaka 569-8686 Japan

TEL

Homepage URL

Email

Institute

Second Department of Internal Medicine, Osaka Medical College

Institute

Department

Personal name

Organization

None

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

Date of disclosure of the study information

2012

Year

12

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2011

Year

09

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

12

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

12

Month

04

Day

Last modified on

2012

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011123