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Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis

Information source: Severance Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: Naproxen/Esomeprazol 500/20mg (Drug); Celecoxib 200mg (Drug); Naxozol-Placebo (Drug); Comparator-Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Severance Hospital

Official(s) and/or principal investigator(s):
Seong-Hwan Moon, M.D., Ph.D., Study Chair, Affiliation: Severance Hospital

Overall contact:
Seong-Hwan Moon, M.D., Ph.D., Phone: 82 2 2228 5670, Email: shmoon@yuhs.ac

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Leads Dyspepsia Questionnaire (LDQ) Change

Secondary outcome:

Mean LDQ

Gastrointestinal Symptom Rating Scale (GSRS) Change

Gastrointestinal Adverse Events Rate

Drug Discontinuation Rate Due to Gastrointestinal Adverse Events

Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)

Quality of Life Change, mean change from baseline of EQ-5D

Treatment Compliance

Rescue Drugs Usage

Adverse Events

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Seong-Hwan Moon, M.D., Ph.D., Phone: 82 2 2228 5670, Email: shmoon@yuhs.ac

Hallym University Medical Center, Anyang-si, Korea, Republic of; Not yet recruiting
Moon-Soo Park, M.D., Principal Investigator

Inje University Ilsan Paik Hospital, Goyang-si, Korea, Republic of; Not yet recruiting
Jin-Hwan Kim, M.D., Principal Investigator

Seoul National University Bundang Hospital, Seongnam-si, Korea, Republic of; Not yet recruiting
Ho-Joong Kim, M.D., Principal Investigator

Asan Medical Center, Seoul, Korea, Republic of; Not yet recruiting
Ho-Seong Lee, M.D., Principal Investigator

Ewha Womans University Medical Center, Seoul, Korea, Republic of; Not yet recruiting
Sang-Jin Shin, M.D., Principal Investigator

Gangnam Severance Hospital, Seoul, Korea, Republic of; Not yet recruiting
Woo-Suk Lee, M.D., Principal Investigator

Hanyang University Seoul Hospital, Seoul, Korea, Republic of; Not yet recruiting
Chang-Nam Kang, M.D., Principal Investigator

Seoul National University Hospital, Seoul, Korea, Republic of; Not yet recruiting
Sang-Hoon Lee, M.D., Principal Investigator

Seoul St. Mary's Hospital, Seoul, Korea, Republic of; Not yet recruiting
Young-Hoon Kim, M.D., Principal Investigator

Severance Hospital, Seoul, Korea, Republic of; Recruiting
Seong-Hwan Moon, M.D., Principal Investigator

Additional Information

Starting date: February 2015
Last updated: March 20, 2015

Page last updated: August 20, 2015

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