Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Spondylitis, Ankylosing
Drug: Part I - etoricoxib 60 mg
Drug: Part I - etoricoxib 90 mg
Drug: Part I- naproxen 1000 mg
Drug: Part I - Placebo to naproxen 500 mg
Drug: Part II- etoricoxib 60 mg
Drug: Part II- etoricoxib 90 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
Drug: Part II- Placebo to naproxen 500 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

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 [ 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 ]

Estimated Enrollment: 900
Study Start Date: September 2010
Estimated Study Completion Date: November 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Part I - etoricoxib 60 mg
etoricoxib 60 mg oral tablet once daily for 6 weeks
Other Name: MK-0663
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 I - Placebo to etoricoxib 90 mg
Placebo to etoricoxib 90 mg oral tablet once daily for 6 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 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
Drug: Part I - etoricoxib 60 mg
etoricoxib 60 mg oral tablet once daily for 6 weeks
Other Name: MK-0663
Drug: Part I - Placebo to naproxen 500 mg
Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks
Drug: Part II- etoricoxib 90 mg
etoricoxib 90 mg oral tablet once daily for 20 weeks
Other Name: MK-0663
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 naproxen 500 mg
Placebo to naproxen 500 mg orally twice daily for 20 weeks.
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
Drug: Part I - etoricoxib 90 mg
etoricoxib 90 mg oral tablet once daily for 6 weeks
Other Name: Mk-0663
Drug: Part I - Placebo to naproxen 500 mg
Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks
Drug: Part II- etoricoxib 90 mg
etoricoxib 90 mg oral tablet once daily for 20 weeks
Other Name: MK-0663
Drug: Part I - Placebo to etoricoxib 60 mg
Placebo to etoricoxib 60 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 naproxen 500 mg
Placebo to naproxen 500 mg orally twice daily for 20 weeks.
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
Drug: Part I- naproxen 1000 mg
naproxen 500 mg oral tablet twice daily for 6 weeks
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01208207     History of Changes
Other Study ID Numbers: 0663-108
Study First Received: September 22, 2010
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Etoricoxib
Naproxen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014