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A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)

Primary Purpose

Spondylitis, Ankylosing

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Part I - etoricoxib 60 mg
Part I - etoricoxib 90 mg
Part I- naproxen 1000 mg
Part I - Placebo to naproxen 500 mg
Part II- etoricoxib 60 mg
Part II- etoricoxib 90 mg
Part II- naproxen 1000 mg
Part I - Placebo to etoricoxib 60 mg
Part I - Placebo to etoricoxib 90 mg
Part II- Placebo to etoricoxib 60 mg
Part II - Placebo to etoricoxib 90 mg
Part II- Placebo to naproxen 500 mg
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylitis, Ankylosing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a definite diagnosis of Ankylosing Spondylitis (AS) per Modified New York Criteria made at least 6 months prior to screening
  • Has a history of positive therapeutic benefit with non-steroidal anti-inflammatory drugs (NSAIDs) and regular use of NSAIDS for past 30 days
  • Has a score on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at screening visit that is <77 mm
  • Must demonstrate sufficient "flare" or worsening of AS pain
  • Is in general good health (other than AS)
  • Has had approved non-study antirheumatic therapy that has been at stable dosing AND is not anticipated to undergo a change within the first 6 weeks of the protocol

Exclusion Criteria:

  • Has inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis [DISH]), polymyalgia rheumatica, a history of septic arthritis or intra-articular fracture of the study joint, Wilson's disease, hemachromatosis, ochronosis, or primary osteochondromatosis
  • Has acute peripheral articular disease (onset within 4 weeks prior to screening) of an active (painful or swollen) peripheral arthritis
  • Has a history of gastric or biliary surgery, or small intestine surgery that causes clinical malabsorption
  • Has had an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease
  • Has undergone coronary artery bypass graft surgery (CABG), angioplasty, or has a cerebrovascular accident or transient ischemic attack within the past 6 months or has active ischemic heart disease, cerebrovascular disease, or peripheral vascular disease
  • Has Class II-IV congestive heart failure
  • Has uncontrolled hypertension
  • Has a history of neoplastic disease, except adequately treated basal cell carcinoma or carcinoma in situ of the cervix, or malignancies that have been successfully treated ≥ 5 years prior to screening
  • Has history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease
  • Allergy to etoricoxib or naproxen, or history of a significant clinical or laboratory adverse experience associated with etoricoxib or naproxen
  • Has a history or family history of an inherited or acquired bleeding disorder
  • Is considered morbidly obese and demonstrates significant health problems stemming from obesity, which would confound study participation or interpretation of study results
  • Is pregnant, breast-feeding, or expecting to conceive during the study
  • Has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥ 5

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    etoricoxib 60 mg/etoricoxib 60 mg

    etoricoxib 60 mg/etoricoxib 90 mg

    etoricoxib 90 mg/etoricoxib 90 mg

    naproxen 1000 mg/naproxen 1000 mg

    Arm Description

    The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg in Part I and Part II

    The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg in Part I and etoricoxib 90 mg in Part II

    The etoricoxib 90 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg in Part I and Part II

    The naproxen 1000 mg/naproxen 1000 mg treatment sequence will receive naproxen 1000 mg in Part I and Part II

    Outcomes

    Primary Outcome Measures

    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
    Number of Participants Discontinuing Study Treatment Due to an Adverse Event

    Secondary Outcome Measures

    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
    Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6.

    Full Information

    First Posted
    September 22, 2010
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01208207
    Brief Title
    A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)
    Official Title
    A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 27, 2010 (Actual)
    Primary Completion Date
    November 12, 2014 (Actual)
    Study Completion Date
    November 12, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the efficacy and tolerability of two doses of etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary objectives are to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg compared with etoricoxib 60 mg. Additionally the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study. The primary hypothesis is that the improvement in Spinal Pain Intensity visual analog scale (VAS) as measured by the time-weighted average (TWA) change from baseline over 6 weeks of treatment in Part I for etoricoxib 90 mg or 60 mg once daily is not inferior to naproxen 1000 mg.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spondylitis, Ankylosing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1015 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    etoricoxib 60 mg/etoricoxib 60 mg
    Arm Type
    Experimental
    Arm Description
    The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg in Part I and Part II
    Arm Title
    etoricoxib 60 mg/etoricoxib 90 mg
    Arm Type
    Experimental
    Arm Description
    The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg in Part I and etoricoxib 90 mg in Part II
    Arm Title
    etoricoxib 90 mg/etoricoxib 90 mg
    Arm Type
    Experimental
    Arm Description
    The etoricoxib 90 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg in Part I and Part II
    Arm Title
    naproxen 1000 mg/naproxen 1000 mg
    Arm Type
    Active Comparator
    Arm Description
    The naproxen 1000 mg/naproxen 1000 mg treatment sequence will receive naproxen 1000 mg in Part I and Part II
    Intervention Type
    Drug
    Intervention Name(s)
    Part I - etoricoxib 60 mg
    Other Intervention Name(s)
    MK-0663
    Intervention Description
    etoricoxib 60 mg oral tablet once daily for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Part I - etoricoxib 90 mg
    Other Intervention Name(s)
    Mk-0663
    Intervention Description
    etoricoxib 90 mg oral tablet once daily for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Part I- naproxen 1000 mg
    Intervention Description
    naproxen 500 mg oral tablet twice daily for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Part I - Placebo to naproxen 500 mg
    Intervention Description
    Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Part II- etoricoxib 60 mg
    Other Intervention Name(s)
    MK-0663
    Intervention Description
    etoricoxib 60 mg oral tablet once daily for 20 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Part II- etoricoxib 90 mg
    Other Intervention Name(s)
    MK-0663
    Intervention Description
    etoricoxib 90 mg oral tablet once daily for 20 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Part II- naproxen 1000 mg
    Intervention Description
    naproxen 500 mg oral tablet twice daily for 20 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Part I - Placebo to etoricoxib 60 mg
    Intervention Description
    Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Part I - Placebo to etoricoxib 90 mg
    Intervention Description
    Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Part II- Placebo to etoricoxib 60 mg
    Intervention Description
    Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Part II - Placebo to etoricoxib 90 mg
    Intervention Description
    Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Part II- Placebo to naproxen 500 mg
    Intervention Description
    Placebo to naproxen 500 mg orally twice daily for 20 weeks.
    Primary Outcome Measure Information:
    Title
    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen
    Description
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
    Time Frame
    Baseline and up to Week 6
    Title
    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen
    Description
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
    Time Frame
    Baseline and up to Week 6
    Title
    Number of Participants Discontinuing Study Treatment Due to an Adverse Event
    Time Frame
    Up to 26 weeks
    Secondary Outcome Measure Information:
    Title
    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg
    Description
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
    Time Frame
    Baseline and up to Week 6
    Title
    Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)
    Description
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6.
    Time Frame
    Week 6 to Week 10 and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has a definite diagnosis of Ankylosing Spondylitis (AS) per Modified New York Criteria made at least 6 months prior to screening Has a history of positive therapeutic benefit with non-steroidal anti-inflammatory drugs (NSAIDs) and regular use of NSAIDS for past 30 days Has a score on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at screening visit that is <77 mm Must demonstrate sufficient "flare" or worsening of AS pain Is in general good health (other than AS) Has had approved non-study antirheumatic therapy that has been at stable dosing AND is not anticipated to undergo a change within the first 6 weeks of the protocol Exclusion Criteria: Has inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis [DISH]), polymyalgia rheumatica, a history of septic arthritis or intra-articular fracture of the study joint, Wilson's disease, hemachromatosis, ochronosis, or primary osteochondromatosis Has acute peripheral articular disease (onset within 4 weeks prior to screening) of an active (painful or swollen) peripheral arthritis Has a history of gastric or biliary surgery, or small intestine surgery that causes clinical malabsorption Has had an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease Has undergone coronary artery bypass graft surgery (CABG), angioplasty, or has a cerebrovascular accident or transient ischemic attack within the past 6 months or has active ischemic heart disease, cerebrovascular disease, or peripheral vascular disease Has Class II-IV congestive heart failure Has uncontrolled hypertension Has a history of neoplastic disease, except adequately treated basal cell carcinoma or carcinoma in situ of the cervix, or malignancies that have been successfully treated ≥ 5 years prior to screening Has history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease Allergy to etoricoxib or naproxen, or history of a significant clinical or laboratory adverse experience associated with etoricoxib or naproxen Has a history or family history of an inherited or acquired bleeding disorder Is considered morbidly obese and demonstrates significant health problems stemming from obesity, which would confound study participation or interpretation of study results Is pregnant, breast-feeding, or expecting to conceive during the study Has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥ 5
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    27737664
    Citation
    Balazcs E, Sieper J, Bickham K, Mehta A, Frontera N, Stryszak P, Popmihajlov Z, Peloso PM. A randomized, clinical trial to assess the relative efficacy and tolerability of two doses of etoricoxib versus naproxen in patients with ankylosing spondylitis. BMC Musculoskelet Disord. 2016 Oct 13;17(1):426. doi: 10.1186/s12891-016-1275-5.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=0663-108&kw=0663-108&tab=access

    Learn more about this trial

    A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)

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