NCT00862628

Brief Summary

The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

8 months

First QC Date

March 16, 2009

Last Update Submit

September 18, 2009

Conditions

NSAIDs-induced Small-intestinal Injuries

Outcome Measures

Primary Outcomes (1)

  • The number of mucosal breaks

    4 and 8 weeks after treatment

Study Arms (1)

Rebamipide

EXPERIMENTAL
Drug: Rebamipide

Interventions

RebamipideDRUG

100mg tid, 4 or 8 weeks

Rebamipide

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • to 85 years of age
  • RA, OA, or low back pain
  • No change of drugs before 3 months
  • Under 5 mg of corticosteroid use
  • CRP \< 1mg/dl
  • Small-intestinal mucosal injuries more than one
  • Hemoglobin level is below normal range

You may not qualify if:

  • Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
  • Prostaglandins, metronidazole or salazosulfapyridine
  • Can not swallow
  • Eith pacemaker
  • After gastrointestinal operation
  • Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
  • Taking rebamipide before one week
  • Any other conditions that the investigator feels would interfere with data interpretation or create under risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Gastroenterology, Nagoya University Graduate School of Medicine

Nagoya, Aichi-ken, 466-8550, Japan

Location

Department of Gastroenterology, Nagoya University Graduate School of Medicine

Nagoya, Aichi-ken, 466-8550, Japan

Location

MeSH Terms

Interventions

rebamipide

Study Officials

  • Naoki Ohmiya, M.D., Ph.D.

    Nagoya University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naoki Ohmiya, MD., Ph.D.

CONTACT

81-52-744-2172nohmiya@med.nagoya-u.ac.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Study Completion

October 1, 2010

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

JP(2)