A Phase 4 interventional study of Naproxen/Esomeprazol 500/20mg and Celecoxib 200mg in Osteoarthritis, sponsored by Severance Hospital. Status unknown at 10 sites in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-03-23.
Sponsored by Severance Hospital · Phase 4, Interventional, and Treatment
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.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's planned enrollment of 106 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Severance Hospital is the lead sponsor of 50 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Naproxen/Esomeprazol 500/20mg and Comparator-Placebo for 12 weeks
Drug: Naproxen/Esomeprazol 500/20mg · Drug: Comparator-Placebo
Celecoxib 200mg and Naxozol-Placebo for 12 weeks
Drug: Celecoxib 200mg · Drug: Naxozol-Placebo
Tablet, b.i.d.
Also known as: Naxozol
Capsule, o.d.
Also known as: Celebrex
Tablet (which is identical to Naxozol), b.i.d.
Capsule (which is identical to Celebrex), o.d.
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
Acetaminophen 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
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Severance Hospital