OsteoarthritisPhase 4NCT02355236
Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis
A Phase 4 study testing Naproxen/Esomeprazol 500/20mg and Celecoxib 200mg in people with Osteoarthritis, run by Severance Hospital at 10 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Naproxen/Esomeprazol 500/20mg and Celecoxib 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Feb 2015to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Not yet recruiting
Hallym University Medical Center
Anyang-si
Moon-Soo Park, M.D.
- Not yet recruiting
Inje University Ilsan Paik Hospital
Goyang-si
Jin-Hwan Kim, M.D.
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si
Ho-Joong Kim, M.D.
- Not yet recruiting
Asan Medical Center
Seoul
Ho-Seong Lee, M.D.
- Not yet recruiting
Ewha Womans University Medical Center
Seoul
Sang-Jin Shin, M.D.
- Not yet recruiting
Gangnam Severance Hospital
Seoul
Woo-Suk Lee, M.D.
- Not yet recruiting
Hanyang University Seoul Hospital
Seoul
Chang-Nam Kang, M.D.
- Not yet recruiting
Seoul National University Hospital
Seoul
Sang-Hoon Lee, M.D.
- Not yet recruiting
Seoul St. Mary's Hospital
Seoul
Young-Hoon Kim, M.D.
- Recruiting
Severance Hospital
Seoul
Seong-Hwan Moon, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Naproxen/Esomeprazol 500/20mg, Celecoxib 200mg, Naxozol-Placebo, Comparator-Placebo
- Keywords
- Naxozol, LDQ, GSRS, Osteoarthritis, Gastroprotective
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen/Esomeprazol 500/20mgDrug
Also called Naxozol
Tablet, b.i.d.
Celecoxib 200mgDrug
Also called Celebrex
Capsule, o.d.
Naxozol-PlaceboDrug
Tablet (which is identical to Naxozol), b.i.d.
Comparator-PlaceboDrug
Capsule (which is identical to Celebrex), o.d.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Naproxen/Esomeprazol 500/20mg and Comparator-Placebo for 12 weeks Receives: Drug: Naproxen/Esomeprazol 500/20mg; Drug: Comparator-Placebo |
| Comparator Group | Active comparator | Celecoxib 200mg and Naxozol-Placebo for 12 weeks Receives: Drug: Celecoxib 200mg; Drug: Naxozol-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leads Dyspepsia Questionnaire (LDQ) Change
Mean change from baseline of Leads Dyspepsia Questionnaire
Measured: Baseline, 12 weeks
Secondary outcomes (9)
Mean LDQ
Mean value of Leads Dyspepsia Questionnaire at 12 weeks
Measured: Baseline, 12 weeks
Gastrointestinal Symptom Rating Scale (GSRS) Change
Mean change from baseline of Gastrointestinal Symptom Rating Scale
Measured: Baseline, 12 weeks
Gastrointestinal Adverse Events Rate
Dyspepsia, Diarrhoea, Nausea, Abdominal Pain, Heartburn
Measured: Baseline, 12 weeks
Drug Discontinuation Rate Due to Gastrointestinal Adverse Events
Measured: Baseline, 12 weeks
Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)
Mean change from baseline of Pain Visual Analogue Scale (VAS)
Measured: Baseline, 12 weeks
Quality of Life Change, mean change from baseline of EQ-5D
Mean change from baseline of EQ-5D
Measured: Baseline, 12 weeks
Treatment Compliance
Non-compliance is defined less than 80%
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
Adverse Events
Adverse Events and Abnormalities from Vital Signs, Physical Exam, and Clinical Laboratories
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Hwan Moon, Severance Hospital
- Investigators
- Seong-Hwan Moon, M.D., Ph.D., Study chair, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355236
- Sponsor's protocol ID
- Naxozol_P4_1
- Status last verified
- Mar 2015
- First submitted
- 30 Jan 2015
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02355236
- Acronym / sponsor ID
- Naxozol_P4_1
- Conditions
- Osteoarthritis
- Keywords
- Naxozol, LDQ, GSRS, Osteoarthritis, Gastroprotective
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Naproxen/Esomeprazol 500/20mg, Drug: Comparator-PlaceboNaproxen/Esomeprazol 500/20mg and Comparator-Placebo for 12 weeks |
| Comparator Group | Active comparator | Drug: Celecoxib 200mg, Drug: Naxozol-PlaceboCelecoxib 200mg and Naxozol-Placebo for 12 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen/Esomeprazol 500/20mgAlso: NaxozolTablet, b.i.d. | Drug | Test Group |
| Celecoxib 200mgAlso: CelebrexCapsule, o.d. | Drug | Comparator Group |
| Naxozol-PlaceboTablet (which is identical to Naxozol), b.i.d. | Drug | Comparator Group |
| Comparator-PlaceboCapsule (which is identical to Celebrex), o.d. | Drug | Test Group |
Primary outcome
Leads Dyspepsia Questionnaire (LDQ) Change
Time frame: Baseline, 12 weeks
Mean change from baseline of Leads Dyspepsia Questionnaire
9 secondary outcomes
Mean LDQ
Time frame: Baseline, 12 weeks
Gastrointestinal Symptom Rating Scale (GSRS) Change
Time frame: Baseline, 12 weeks
Gastrointestinal Adverse Events Rate
Time frame: Baseline, 12 weeks
Drug Discontinuation Rate Due to Gastrointestinal Adverse Events
Time frame: Baseline, 12 weeks
Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS)
Time frame: Baseline, 12 weeks
Quality of Life Change, mean change from baseline of EQ-5D
Time frame: Baseline, 12 weeks
Treatment Compliance
Time frame: Baseline, 12 weeks
Rescue Drugs Usage
Time frame: Baseline, 12 weeks
Adverse Events
Time frame: Baseline, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong-Hwan Moon, M.D., Ph.D. study chair
Severance Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen/Esomeprazol 500/20mg and Celecoxib 200mg in people with Osteoarthritis, run by Severance Hospital at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong-Hwan Moon, M.D., Ph.D. (82 2 2228 5670, shmoon@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leads Dyspepsia Questionnaire (LDQ) Change (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.