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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02355236
• Other study ID #: Naxozol_P4_1
• Status: Recruiting
• Phase: Phase 4
• First received: January 30, 2015
• Last updated: March 20, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Severance Hospital
• Contact: Seong-Hwan Moon, M.D., Ph.D.
• Phone: 82 2 2228 5670
• Email: shmoon[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Naproxen/Esomeprazol 500/20mg
Tablet, b.i.d.
• Celecoxib 200mg
Capsule, o.d.
• Naxozol-Placebo
Tablet (which is identical to Naxozol), b.i.d.
• Comparator-Placebo
Capsule (which is identical to Celebrex), o.d.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang-si
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leads Dyspepsia Questionnaire (LDQ) Change	Mean change from baseline of Leads Dyspepsia Questionnaire	Baseline, 12 weeks	Yes
Secondary	Mean LDQ	Mean value of Leads Dyspepsia Questionnaire at 12 weeks	Baseline, 12 weeks	Yes
Secondary	Gastrointestinal Symptom Rating Scale (GSRS) Change	Mean change from baseline of Gastrointestinal Symptom Rating Scale	Baseline, 12 weeks	Yes
Secondary	Gastrointestinal Adverse Events Rate	Dyspepsia, Diarrhoea, Nausea, Abdominal Pain, Heartburn	Baseline, 12 weeks	Yes
Secondary	Drug Discontinuation Rate Due to Gastrointestinal Adverse Events		Baseline, 12 weeks	Yes
Secondary	Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)	Mean change from baseline of Pain Visual Analogue Scale (VAS)	Baseline, 12 weeks	No
Secondary	Quality of Life Change, mean change from baseline of EQ-5D	Mean change from baseline of EQ-5D	Baseline, 12 weeks	No
Secondary	Treatment Compliance	Non-compliance is defined less than 80%	Baseline, 12 weeks	No
Secondary	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.	Baseline, 12 weeks	No
Secondary	Adverse Events	Adverse Events and Abnormalities from Vital Signs, Physical Exam, and Clinical Laboratories	Baseline, 12 weeks	Yes