search
Back to results

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity (PRESENT)

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rebamipide
Misoprostol
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Therapeutic failure
Severity of gastrointestinal symptoms
Antacid consumption

Full Information

First Posted
December 17, 2007
Last Updated
November 15, 2011
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00576706
Brief Title
PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity
Acronym
PRESENT
Official Title
A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis
Keywords
Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Other Intervention Name(s)
Mucosta
Intervention Description
Rebamipide 100㎎, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec®
Intervention Description
Misoprostol 200㎍ 12 weeks
Primary Outcome Measure Information:
Title
Incidence rate of gastric ulcer on gastroendoscopy result at 12-week
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Rate of Therapeutic failure
Time Frame
12 weeks
Title
Severity of gastrointestinal symptoms
Time Frame
12 weeks
Title
Antacid consumption
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Heon Park, MD PhD
Organizational Affiliation
Catholic University Hospital
Official's Role
Principal Investigator
Facility Information:
City
Bucheon
Country
Korea, Republic of
City
Chonju
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Jinju
Country
Korea, Republic of
City
Pusan
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

We'll reach out to this number within 24 hrs