Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Naproxen/Esomeprazol 500/20mg
Celecoxib 200mg
Naxozol-Placebo
Comparator-Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Naxozol, LDQ, GSRS, Osteoarthritis, Gastroprotective
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
Sites / Locations
- Hallym University Medical Center
- Inje University Ilsan Paik Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- Ewha Womans University Medical Center
- Gangnam Severance Hospital
- Hanyang University Seoul Hospital
- Seoul National University Hospital
- Seoul St. Mary's Hospital
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Group
Comparator Group
Arm Description
Naproxen/Esomeprazol 500/20mg and Comparator-Placebo for 12 weeks
Celecoxib 200mg and Naxozol-Placebo for 12 weeks
Outcomes
Primary Outcome Measures
Leads Dyspepsia Questionnaire (LDQ) Change
Mean change from baseline of Leads Dyspepsia Questionnaire
Secondary Outcome Measures
Mean LDQ
Mean value of Leads Dyspepsia Questionnaire at 12 weeks
Gastrointestinal Symptom Rating Scale (GSRS) Change
Mean change from baseline of Gastrointestinal Symptom Rating Scale
Gastrointestinal Adverse Events Rate
Dyspepsia, Diarrhoea, Nausea, Abdominal Pain, Heartburn
Drug Discontinuation Rate Due to Gastrointestinal Adverse Events
Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)
Mean change from baseline of Pain Visual Analogue Scale (VAS)
Quality of Life Change, mean change from baseline of EQ-5D
Mean change from baseline of EQ-5D
Treatment Compliance
Non-compliance is defined less than 80%
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.
Adverse Events
Adverse Events and Abnormalities from Vital Signs, Physical Exam, and Clinical Laboratories
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02355236
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Severance Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Naxozol, LDQ, GSRS, Osteoarthritis, Gastroprotective
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Experimental
Arm Description
Naproxen/Esomeprazol 500/20mg and Comparator-Placebo for 12 weeks
Arm Title
Comparator Group
Arm Type
Active Comparator
Arm Description
Celecoxib 200mg and Naxozol-Placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Naproxen/Esomeprazol 500/20mg
Other Intervention Name(s)
Naxozol
Intervention Description
Tablet, b.i.d.
Intervention Type
Drug
Intervention Name(s)
Celecoxib 200mg
Other Intervention Name(s)
Celebrex
Intervention Description
Capsule, o.d.
Intervention Type
Drug
Intervention Name(s)
Naxozol-Placebo
Intervention Description
Tablet (which is identical to Naxozol), b.i.d.
Intervention Type
Drug
Intervention Name(s)
Comparator-Placebo
Intervention Description
Capsule (which is identical to Celebrex), o.d.
Primary Outcome Measure Information:
Title
Leads Dyspepsia Questionnaire (LDQ) Change
Description
Mean change from baseline of Leads Dyspepsia Questionnaire
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Mean LDQ
Description
Mean value of Leads Dyspepsia Questionnaire at 12 weeks
Time Frame
Baseline, 12 weeks
Title
Gastrointestinal Symptom Rating Scale (GSRS) Change
Description
Mean change from baseline of Gastrointestinal Symptom Rating Scale
Time Frame
Baseline, 12 weeks
Title
Gastrointestinal Adverse Events Rate
Description
Dyspepsia, Diarrhoea, Nausea, Abdominal Pain, Heartburn
Time Frame
Baseline, 12 weeks
Title
Drug Discontinuation Rate Due to Gastrointestinal Adverse Events
Time Frame
Baseline, 12 weeks
Title
Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)
Description
Mean change from baseline of Pain Visual Analogue Scale (VAS)
Time Frame
Baseline, 12 weeks
Title
Quality of Life Change, mean change from baseline of EQ-5D
Description
Mean change from baseline of EQ-5D
Time Frame
Baseline, 12 weeks
Title
Treatment Compliance
Description
Non-compliance is defined less than 80%
Time Frame
Baseline, 12 weeks
Title
Rescue Drugs Usage
Description
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
Title
Adverse Events
Description
Adverse Events and Abnormalities from Vital Signs, Physical Exam, and Clinical Laboratories
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seong-Hwan Moon, M.D., Ph.D.
Phone
82 2 2228 5670
Email
shmoon@yuhs.ac
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Hye Kim
Phone
82 2 2228 2824
Email
CORN@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hwan Moon, M.D., Ph.D.
Organizational Affiliation
Severance Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang-si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moon-Soo Park, M.D.
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang-si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Hwan Kim, M.D.
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-Joong Kim, M.D.
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-Seong Lee, M.D.
Facility Name
Ewha Womans University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Jin Shin, M.D.
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo-Suk Lee, M.D.
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Nam Kang, M.D.
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Hoon Lee, M.D.
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Hoon Kim, M.D.
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong-Hwan Moon, M.D.
12. IPD Sharing Statement
Learn more about this trial
Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis
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