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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01208207
First received: September 22, 2010
Last updated: July 7, 2015
Last verified: July 2015
Results First Received: May 4, 2015  
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
Condition: Spondylitis, Ankylosing
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All Patients Randomized

Reporting Groups
  Description
Etoricoxib 60 mg (Part I) Etoricoxib 60 mg oral tablet once daily for 6 weeks
Etoricoxib 90 mg (Part I) Etoricoxib 90 mg oral tablet once daily for 6 weeks
Naproxen 1000 mg (Part I) Naproxen 500 mg oral tablet twice daily for 6 weeks
Etoricoxib 60 mg / 60 mg (Part II) A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
Etoricoxib 60 mg / 90 mg (Part II) An increase of etoricoxib to 90 mg for 20 weeks (Part II)
Etoricoxib 90 mg / 90 mg (Part II) A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
Naproxen 1000 mg (Part II) A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)

Participant Flow for 2 periods

Period 1:   Part I
    Etoricoxib 60 mg (Part I)     Etoricoxib 90 mg (Part I)     Naproxen 1000 mg (Part I)     Etoricoxib 60 mg / 60 mg (Part II)     Etoricoxib 60 mg / 90 mg (Part II)     Etoricoxib 90 mg / 90 mg (Part II)     Naproxen 1000 mg (Part II)  
STARTED     702     156     157     0     0     0     0  
COMPLETED     632     145     142     0     0     0     0  
NOT COMPLETED     70     11     15     0     0     0     0  
Adverse Event                 19                 2                 6                 0                 0                 0                 0  
Lack of Efficacy                 21                 3                 2                 0                 0                 0                 0  
Lost to Follow-up                 6                 1                 0                 0                 0                 0                 0  
Non-Compliance With Study Drug                 1                 0                 1                 0                 0                 0                 0  
Physician Decision                 0                 1                 0                 0                 0                 0                 0  
Progressive Disease                 1                 0                 0                 0                 0                 0                 0  
Protocol Violation                 8                 0                 2                 0                 0                 0                 0  
Withdrawal by Subject                 14                 4                 4                 0                 0                 0                 0  

Period 2:   Part II
    Etoricoxib 60 mg (Part I)     Etoricoxib 90 mg (Part I)     Naproxen 1000 mg (Part I)     Etoricoxib 60 mg / 60 mg (Part II)     Etoricoxib 60 mg / 90 mg (Part II)     Etoricoxib 90 mg / 90 mg (Part II)     Naproxen 1000 mg (Part II)  
STARTED     0     0     0     314     318     145     142  
COMPLETED     0     0     0     282     295     129     131  
NOT COMPLETED     0     0     0     32     23     16     11  
Withdrawal by Subject                 0                 0                 0                 10                 9                 3                 5  
Adverse Event                 0                 0                 0                 5                 9                 4                 2  
Lack of Efficacy                 0                 0                 0                 6                 4                 3                 3  
Lost to Follow-up                 0                 0                 0                 4                 0                 2                 1  
Non-Compliance With Study Drug                 0                 0                 0                 4                 1                 1                 0  
Physician Decision                 0                 0                 0                 1                 0                 2                 0  
Protocol Violation                 0                 0                 0                 1                 0                 0                 0  
Technical Problems                 0                 0                 0                 1                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Etoricoxib 60 mg Etoricoxib 60 mg oral tablet once daily
Etoricoxib 90 mg Etoricoxib 90 mg once daily
Naproxen 1000 mg Naproxen 500 mg oral tablet twice daily
Total Total of all reporting groups

Baseline Measures
    Etoricoxib 60 mg     Etoricoxib 90 mg     Naproxen 1000 mg     Total  
Number of Participants  
[units: participants]
  702     156     157     1015  
Age  
[units: Years]
Mean (Standard Deviation)
  45.4  (12.4)     45.2  (11.3)     44.5  (12.3)     45.2  (12.2)  
Gender  
[units: Participants]
       
Female     209     45     41     295  
Male     493     111     116     720  
Spinal Pain Intensity [1]
[units: mm┬áVAS]
Mean (Standard Deviation)
  76.7  (14.2)     76.7  (15.2)     77.0  (14.0)     76.8  (14.3)  
[1] Visual Analogue Scale from 0-100 mm with a lower value representing a better response.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   Number of Participants Discontinuing Study Treatment Due to an Adverse Event   [ Time Frame: Up to 26 weeks ]

4.  Secondary:   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 ]

5.  Secondary:   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 Week 10 and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


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
Results First Received: May 4, 2015
Last Updated: July 7, 2015
Health Authority: United States: Food and Drug Administration