Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy

NCT00641004 | Completed Phase 4

• 1 other identifier: 037-PPB-0701i
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

Primary objective: To determine the levels of malondialdehyde (MDA) and immunohistochemistry surrogate of inflammation in patients with NSAID-induced gastric mucosal injury treated with Rebamipide 3x a day vs Esomeprazole 40mg once a day. Secondary objective: For patients who become symptomatic during NSAID treatment, to compare the proportion of patients with positive treatment effects using the Likert scale. Third objective: To compare the proportion of patients with positive treatment effects as determined by Modified Lanza scoring between the two groups.

Conditions

NSAID Induced Gastropathy

Outcome Measures

Primary Outcomes (1)

• To determine the levels of MDA and immunohistochemistry surrogate of inflammation in patients with NSAID-induced gastric mucosal injury.

  Throughout the study

Secondary Outcomes (1)

• For patients who become symptomatic during NSAID treatment, to compare the proportion of patients with positive treatment effects using the Likert scale

  Throughout the study

Study Arms (2)

1

EXPERIMENTAL

Rebamipide 100mg TID for 12 weeks

Drug: Rebamipide and Esomeprazole

2

ACTIVE COMPARATOR

Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks

Drug: Rebamipide and Esomeprazole

Interventions

Rebamipide and Esomeprazole DRUG

1. Rebamipide 100mg TID for 12 weeks 2. Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with rheumatoid arthritis and osteoarthritis who developed dyspeptic symptoms while on NSAID for at leat 4 weeks who fulfill any of the following criteria: 1) Have not been on NSAIDs (NSAID-naïve) as they are newly diagnosed patients or satisfies ALL of the following criteria: a) Have not received NSAIDs for more than 2 years continuously, b) Have not received NSAID for at least 3 months, c) Does not take more than the therapeutic dose required for any of the following NSAIDS: Aspirin (at max. 4000mg.day), Naproxen (at max. 1375mg/day), Ibupropen (at max. 2400mg/day), Diclofenac (at max. 200mg/day), Piroxicam (at max. 40mg/day). 2) Gastric mucosal lesions on upper endoscopy (Lanza score ≥ 1) 3) More than 18 and less than 65 years old 4) Medically cleared and consents to undergo upper endoscopy 5) Willing to participate in the trial and sign an informed consent form

You may not qualify if:

• \. Patients with known malignancy 2) Women who are pregnant and breastfeeding 3) Psychiatric illness 4) severe co-morbid illness like renal failure, cirrhosis, etc. 5) History of intake of any anti-secretory agent for the past 2 weeks 6) Patients with coagulation disorders and hematologic problems 7) Complicated ulcers, i.e. bleeding, perforating, etc. 8) Patients with evidence of portal hypertension i.e. varices, portal gastropathy, etc. 9) History of gastric surgery 10) Patients on COX-2 inhibitors 11) Modified Lanza score of 0 12) Herbal medications or complementary alternative medicines (e.g. glucosamine chondroitisulfate, etc. 13) (+)H.pylori test by RUT (Rapid Urease Test) and biopsy.

Sponsors & Collaborators

• Otsuka Pharmaceutical, Inc., Philippines: lead

Study Sites (4)

University of Santo Tomas Hospital

Manila, Philippines

Location

Armed Forces of the Philippines Medical Center

Quezon City, Philippines

Location

Veterans Memorial Medical Center

Quezon City, Philippines

Location

Candinal Santos medical Center

San Juan City, Philippines

Location

MeSH Terms

Interventions

rebamipide; Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jose Sollano, MD

  University of Santo Tomas Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 24, 2011

Record last verified: 2009-12

Locations

PH (4)