Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00757627
First received: September 22, 2008
Last updated: April 20, 2010
Last verified: April 2010
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| Tracking Information | |||||
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| First Received Date ICMJE | September 22, 2008 | ||||
| Last Updated Date | April 20, 2010 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4 [ Time Frame: Baseline and end of week 4 ] [ Designated as safety issue: No ] WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain") |
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| Original Primary Outcome Measures ICMJE |
Patient: WOMAC; Brief Pain Inventory EQ-5D; TSQM; Disease impact on work; SF-36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00757627 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Physician: IGART (Investigator Global Assessment of Response to Therapy) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA) | ||||
| Official Title ICMJE | Patient-reported Outcomes With Etoricoxib in Real Life | ||||
| Brief Summary | The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Arcoxia in the normal practice setting. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Drug: etoricoxib
etoricoxib 60 mg QD for 4 weeks.
Other Name: Arcoxia |
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| Study Arm (s) | Experimental: 1
Etoricoxib
Intervention: Drug: etoricoxib |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 500 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00757627 | ||||
| Other Study ID Numbers ICMJE | 2008_029, MK0663-113 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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