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

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ClinicalTrials.gov Identifier: NCT02355236
Recruitment Status : Unknown
Verified March 2015 by Seong-Hwan Moon, Severance Hospital.
Recruitment status was:  Recruiting
First Posted : February 4, 2015
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Seong-Hwan Moon, Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Naproxen/Esomeprazol 500/20mg Drug: Celecoxib 200mg Drug: Naxozol-Placebo Drug: Comparator-Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Test Group
Naproxen/Esomeprazol 500/20mg and Comparator-Placebo for 12 weeks
Drug: Naproxen/Esomeprazol 500/20mg
Tablet, b.i.d.
Other Name: Naxozol

Drug: Comparator-Placebo
Capsule (which is identical to Celebrex), o.d.

Active Comparator: Comparator Group
Celecoxib 200mg and Naxozol-Placebo for 12 weeks
Drug: Celecoxib 200mg
Capsule, o.d.
Other Name: Celebrex

Drug: Naxozol-Placebo
Tablet (which is identical to Naxozol), b.i.d.




Primary Outcome Measures :
  1. Leads Dyspepsia Questionnaire (LDQ) Change [ Time Frame: Baseline, 12 weeks ]
    Mean change from baseline of Leads Dyspepsia Questionnaire


Secondary Outcome Measures :
  1. Mean LDQ [ Time Frame: Baseline, 12 weeks ]
    Mean value of Leads Dyspepsia Questionnaire at 12 weeks

  2. Gastrointestinal Symptom Rating Scale (GSRS) Change [ Time Frame: Baseline, 12 weeks ]
    Mean change from baseline of Gastrointestinal Symptom Rating Scale

  3. Gastrointestinal Adverse Events Rate [ Time Frame: Baseline, 12 weeks ]
    Dyspepsia, Diarrhoea, Nausea, Abdominal Pain, Heartburn

  4. Drug Discontinuation Rate Due to Gastrointestinal Adverse Events [ Time Frame: Baseline, 12 weeks ]
  5. Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS) [ Time Frame: Baseline, 12 weeks ]
    Mean change from baseline of Pain Visual Analogue Scale (VAS)

  6. Quality of Life Change, mean change from baseline of EQ-5D [ Time Frame: Baseline, 12 weeks ]
    Mean change from baseline of EQ-5D

  7. Treatment Compliance [ Time Frame: Baseline, 12 weeks ]
    Non-compliance is defined less than 80%

  8. Rescue Drugs Usage [ Time Frame: Baseline, 12 weeks ]
    Acetaminophen ER 650mg and/or Almagate 500mg will be administrated for control of severe pain events and/or of severe gastrointestinal events.

  9. Adverse Events [ Time Frame: Baseline, 12 weeks ]
    Adverse Events and Abnormalities from Vital Signs, Physical Exam, and Clinical Laboratories



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355236


Contacts
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Contact: Seong-Hwan Moon, M.D., Ph.D. 82 2 2228 5670 shmoon@yuhs.ac
Contact: Ji-Hye Kim 82 2 2228 2824 CORN@yuhs.ac

Locations
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Korea, Republic of
Hallym University Medical Center Not yet recruiting
Anyang-si, Korea, Republic of
Principal Investigator: Moon-Soo Park, M.D.         
Inje University Ilsan Paik Hospital Not yet recruiting
Goyang-si, Korea, Republic of
Principal Investigator: Jin-Hwan Kim, M.D.         
Seoul National University Bundang Hospital Not yet recruiting
Seongnam-si, Korea, Republic of
Principal Investigator: Ho-Joong Kim, M.D.         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Ho-Seong Lee, M.D.         
Ewha Womans University Medical Center Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Sang-Jin Shin, M.D.         
Gangnam Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Woo-Suk Lee, M.D.         
Hanyang University Seoul Hospital Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Chang-Nam Kang, M.D.         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Sang-Hoon Lee, M.D.         
Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Young-Hoon Kim, M.D.         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Seong-Hwan Moon, M.D.         
Sponsors and Collaborators
Severance Hospital
Investigators
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Study Chair: Seong-Hwan Moon, M.D., Ph.D. Severance Hospital

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Responsible Party: Seong-Hwan Moon, Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT02355236     History of Changes
Other Study ID Numbers: Naxozol_P4_1
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Keywords provided by Seong-Hwan Moon, Severance Hospital:
Naxozol
LDQ
GSRS
Osteoarthritis
Gastroprotective
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Naproxen
Esomeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors