Clinical trial NCT02355236: Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Naxozol
LDQ
GSRS
Osteoarthritis
Gastroprotective
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 106
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Leads Dyspepsia Questionnaire (LDQ) Change
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Mean LDQ
timeFrame: Baseline, 12 weeks
measure: Gastrointestinal Symptom Rating Scale (GSRS) Change
timeFrame: Baseline, 12 weeks
measure: Gastrointestinal Adverse Events Rate
timeFrame: Baseline, 12 weeks
measure: Drug Discontinuation Rate Due to Gastrointestinal Adverse Events
timeFrame: Baseline, 12 weeks
measure: Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)
timeFrame: Baseline, 12 weeks
measure: Quality of Life Change, mean change from baseline of EQ-5D
timeFrame: Baseline, 12 weeks
measure: Treatment Compliance
timeFrame: Baseline, 12 weeks
measure: Rescue Drugs Usage
timeFrame: Baseline, 12 weeks
measure: Adverse Events
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Medical Center
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Seong-Hwan Moon, M.D., Ph.D.
role: STUDY_CHAIR
References: