Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis
A Prospective, Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center, Interventional Study to Compare Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis
1 other identifier
interventional
106
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2015
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 23, 2015
March 1, 2015
10 months
January 30, 2015
March 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Leads Dyspepsia Questionnaire (LDQ) Change
Mean change from baseline of Leads Dyspepsia Questionnaire
Baseline, 12 weeks
Secondary Outcomes (9)
Mean LDQ
Baseline, 12 weeks
Gastrointestinal Symptom Rating Scale (GSRS) Change
Baseline, 12 weeks
Gastrointestinal Adverse Events Rate
Baseline, 12 weeks
Drug Discontinuation Rate Due to Gastrointestinal Adverse Events
Baseline, 12 weeks
Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)
Baseline, 12 weeks
- +4 more secondary outcomes
Study Arms (2)
Test Group
EXPERIMENTALNaproxen/Esomeprazol 500/20mg and Comparator-Placebo for 12 weeks
Comparator Group
ACTIVE COMPARATORCelecoxib 200mg and Naxozol-Placebo for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Koreans given informed consent
- Patients who have ability of reading comprehension and completing questionnaires (EQ-5D and VAS)and have willingness to follow-up 12 weeks
- Patients with osteoarthritis symptoms confirmed by his/her medical history and with pain-VAS of 40 and more
You may not qualify if:
- Patients who participate into other interventional study or had participated within 30 days before screening
- Alcohol or drug abuse within 6 months or alcohol consumption of 21 units and more in a week
- Peptic ulcers accompanied with a complication such as bleeding, perforation, penetration or gastric outlet obstruction within 5 years, or a history of active peptic ulcer or peptic ulcer without a complication within 6 months at screening
- Patients who are known with Helicobacter pylori infection but have not received any bacteriostatic treatment
- Known gastroesophageal reflux disease (GERD)
- Any following joint diseases which may significant effect to the efficacy and safety assessments: septic arthritis, inflammatory joint arthritis such as rheumatoid arthritis, gout, recurrent pseudo-pain, Paget's disease, joint fracture, joint ochronosis, acromegaly, hematochromatosis, Wilson's disease, primary osteochondrosis, Ehlers Danlos Syndrome, or other collagen genetic disorder
- Patients who are scheduled admissions to hospital for elective surgery during this study
- History of gastrointestinal cancer
- Gastrointestinal disorders related to drug malabsorption
- Gastrointestinal bleeding, cerebral bleeding, other bleeding disorders, or severe hematological disorders
- Clinically significant diseases such as moderate or severe liver diseases (Child Pough Class II or more), severe heart failure or a history of coronary artery bypass graft (CABG), severe kidney diseases (CrCl\<30ml/min)
- Know allergy experiences with any ingredient of study drugs or with other NASIDs or protocol pump inhibitors (PPIs)
- Patients who had had a joint surgery for osteoarthritis within 1 year
- Women of childbearing potential who do not agree with clinically appropriate contraception during this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Hallym University Medical Center
Anyang-si, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea
Ewha Womans University Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Seong-Hwan Moon, M.D., Ph.D.
Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 30, 2015
First Posted
February 4, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 23, 2015
Record last verified: 2015-03