NCT00576706

Brief Summary

To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
396

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

10 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

2.2 years

First QC Date

December 17, 2007

Last Update Submit

November 15, 2011

Conditions

Rheumatoid ArthritisOsteoarthritisAnkylosing Spondylitis

Keywords

Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of gastric ulcer on gastroendoscopy result at 12-week

    12 weeks

Secondary Outcomes (3)

  • Rate of Therapeutic failure

    12 weeks

  • Severity of gastrointestinal symptoms

    12 weeks

  • Antacid consumption

    12 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Rebamipide

2

ACTIVE COMPARATOR
Drug: Misoprostol

Interventions

RebamipideDRUG

Rebamipide 100㎎, 12 weeks

Also known as: Mucosta
1
MisoprostolDRUG

Misoprostol 200㎍ 12 weeks

Also known as: Cytotec®
2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent after being informed of the clinical trial
  • Males or females 19 years of age
  • Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.

You may not qualify if:

  • Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
  • Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Bucheon-si, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Jinju, South Korea

Location

Unknown Facility

Pusan, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritisSpondylitis, Ankylosing

Interventions

rebamipideMisoprostol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosis

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Soo-Heon Park, MD PhD

    Catholic University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 19, 2007

Study Start

December 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

KR(10)