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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01208207
First received: September 22, 2010
Last updated: September 5, 2014
Last verified: September 2014

September 22, 2010
September 5, 2014
September 2010
June 2014   (final data collection date for primary outcome measure)
  • Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 90 mg vs. naproxen [ Time Frame: Baseline and up to Week 6 ] [ Designated as safety issue: No ]
  • Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 60 mg vs. naproxen [ Time Frame: Baseline and up to Week 6 ] [ Designated as safety issue: No ]
Part I: Spinal pain intensity as measured by a 100mm visual analog scale (VAS), time-weighted average change from baseline, each dose etoricoxib versus naproxen [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Time-weighted average change from baseline in VAS spinal pain intensity will be evaluated between participants who received 90 mg etoricoxib and 60 mg etoricoxib compared to those that received 1000 mg naproxen. The VAS is a 100mm scale with 0 = 'no pain' and 100 = 'extreme pain'. The participant indicates their current pain level by placing a mark along the scale.
Complete list of historical versions of study NCT01208207 on ClinicalTrials.gov Archive Site
  • Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 90 mg vs. etoricoxib 60 mg [ Time Frame: Baseline and up to Week 6 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Week 6 to Weel 10 and Week 12 ] [ Designated as safety issue: No ]
  • Part I: VAS spinal pain intensity, time-weighted average change from baseline, 60 mg etoricoxib versus 90 mg etoricoxib [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Time-weighted average change from baseline in VAS spinal pain intensity will be evaluated between participants who received 90 mg etoricoxib and those who received 60 mg etoricoxib.
  • Part II: VAS spinal pain intensity, time-weighted average change from baseline, 60 mg etoricoxib versus 90 mg etoricoxib [ Time Frame: Beginning after the initial 6 weeks, an additional 20 weeks ] [ Designated as safety issue: No ]
    The incremental benefit of increasing the etoricoxib dose from 60 mg in Part I to 90 mg in Part II, compared to those remaining on 60 mg in Part II will be assessed for change in VAS spinal pain intensity participants who are non-responders during Part I
Not Provided
Not Provided
 
A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Spondylitis, Ankylosing
  • Drug: Part I - etoricoxib 60 mg
    etoricoxib 60 mg oral tablet once daily for 6 weeks
    Other Name: MK-0663
  • Drug: Part I - etoricoxib 90 mg
    etoricoxib 90 mg oral tablet once daily for 6 weeks
    Other Name: Mk-0663
  • Drug: Part I- naproxen 1000 mg
    naproxen 500 mg oral tablet twice daily for 6 weeks
  • Drug: Part I - Placebo to naproxen 500 mg
    Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks
  • Drug: Part II- etoricoxib 60 mg
    etoricoxib 60 mg oral tablet once daily for 20 weeks
    Other Name: MK-0663
  • Drug: Part II- etoricoxib 90 mg
    etoricoxib 90 mg oral tablet once daily for 20 weeks
    Other Name: MK-0663
  • Drug: Part II- naproxen 1000 mg
    naproxen 500 mg oral tablet twice daily for 20 weeks
  • Drug: Part I - Placebo to etoricoxib 60 mg
    Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks.
  • Drug: Part I - Placebo to etoricoxib 90 mg
    Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks.
  • Drug: Part II- Placebo to etoricoxib 60 mg
    Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks.
  • Drug: Part II - Placebo to etoricoxib 90 mg
    Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks.
  • Drug: Part II- Placebo to naproxen 500 mg
    Placebo to naproxen 500 mg orally twice daily for 20 weeks.
  • Experimental: etoricoxib 60 mg/etoricoxib 60 mg
    The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg in Part I and Part II
    Interventions:
    • Drug: Part I - etoricoxib 60 mg
    • Drug: Part I - Placebo to naproxen 500 mg
    • Drug: Part II- etoricoxib 60 mg
    • Drug: Part I - Placebo to etoricoxib 90 mg
    • Drug: Part II - Placebo to etoricoxib 90 mg
    • Drug: Part II- Placebo to naproxen 500 mg
  • Experimental: etoricoxib 60 mg/etoricoxib 90 mg
    The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg in Part I and etoricoxib 90 mg in Part II
    Interventions:
    • Drug: Part I - etoricoxib 60 mg
    • Drug: Part I - Placebo to naproxen 500 mg
    • Drug: Part II- etoricoxib 90 mg
    • Drug: Part I - Placebo to etoricoxib 90 mg
    • Drug: Part II- Placebo to etoricoxib 60 mg
    • Drug: Part II- Placebo to naproxen 500 mg
  • Experimental: etoricoxib 90 mg/etoricoxib 90 mg
    The etoricoxib 90 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg in Part I and Part II
    Interventions:
    • Drug: Part I - etoricoxib 90 mg
    • Drug: Part I - Placebo to naproxen 500 mg
    • Drug: Part II- etoricoxib 90 mg
    • Drug: Part I - Placebo to etoricoxib 60 mg
    • Drug: Part II- Placebo to etoricoxib 60 mg
    • Drug: Part II- Placebo to naproxen 500 mg
  • Active Comparator: naproxen 1000 mg/naproxen 1000 mg
    The naproxen 1000 mg/naproxen 1000 mg treatment sequence will receive naproxen 1000 mg in Part I and Part II
    Interventions:
    • Drug: Part I- naproxen 1000 mg
    • Drug: Part II- naproxen 1000 mg
    • Drug: Part I - Placebo to etoricoxib 60 mg
    • Drug: Part I - Placebo to etoricoxib 90 mg
    • Drug: Part II- Placebo to etoricoxib 60 mg
    • Drug: Part II - Placebo to etoricoxib 90 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
November 2014
June 2014   (final data collection date for primary outcome measure)

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 has 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 (cancer or benign tumor), 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01208207
0663-108
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP