Naxozol is a combination product of naproxen, a non-steroidal anti-inflammatory drug (NSAID) and esomeprazole, a proton pump inhibitor which is designed to improve symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The purpose of this study is to investigate whether naxozol protects the gastrointestinal tract effectively compared to celecoxib, a COX-2 inhibitor.
A total of 10 orthopedic investigators will participate in this study. The effectiveness in gastro-protection of study drug will be assessed by Leeds Dyspepsia Questionnaire (LDQ). The orthopedic investigators will be trained with this questionnaire administration by an expert gastroenterologist prior to starting this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
Tablet, b.i.d.
Capsule, o.d.
Tablet (which is identical to Naxozol), b.i.d.
Hallym University Medical Center
Anyang-si, South Korea
NOT_YET_RECRUITINGInje University Ilsan Paik Hospital
Goyang-si, South Korea
NOT_YET_RECRUITINGSeoul National University Bundang Hospital
Seongnam-si, South Korea
Leads Dyspepsia Questionnaire (LDQ) Change
Mean change from baseline of Leads Dyspepsia Questionnaire
Time frame: Baseline, 12 weeks
Mean LDQ
Mean value of Leads Dyspepsia Questionnaire at 12 weeks
Time frame: Baseline, 12 weeks
Gastrointestinal Symptom Rating Scale (GSRS) Change
Mean change from baseline of Gastrointestinal Symptom Rating Scale
Time frame: Baseline, 12 weeks
Gastrointestinal Adverse Events Rate
Dyspepsia, Diarrhoea, Nausea, Abdominal Pain, Heartburn
Time frame: Baseline, 12 weeks
Drug Discontinuation Rate Due to Gastrointestinal Adverse Events
Time frame: Baseline, 12 weeks
Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)
Mean change from baseline of Pain Visual Analogue Scale (VAS)
Time frame: Baseline, 12 weeks
Quality of Life Change, mean change from baseline of EQ-5D
Mean change from baseline of EQ-5D
Time frame: Baseline, 12 weeks
Treatment Compliance
Non-compliance is defined less than 80%
Time frame: Baseline, 12 weeks
Rescue Drugs Usage
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Capsule (which is identical to Celebrex), o.d.
Asan Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGEwha Womans University Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGGangnam Severance Hospital
Seoul, South Korea
NOT_YET_RECRUITINGHanyang University Seoul Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeoul St. Mary's Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGAcetaminophen ER 650mg and/or Almagate 500mg will be administrated for control of severe pain events and/or of severe gastrointestinal events.
Time frame: Baseline, 12 weeks
Adverse Events
Adverse Events and Abnormalities from Vital Signs, Physical Exam, and Clinical Laboratories
Time frame: Baseline, 12 weeks