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Survey of Osteoarthritis Real World Therapies (MK-0663-140) (SORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01294696
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : March 4, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Osteoarthritis
Intervention: Drug: Standard of care for treatment of osteoarthritis (OA) of knee(s)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted in 54 trial centers: 18 in France; 4 in Italy; 5 in The Netherlands; 5 in Portugal; and 9 in the United Kingdom.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Enrolled Participants The population consisted of all enrolled participants with adequate and inadequate pain relief.

Participant Flow:   Overall Study
    All Enrolled Participants
STARTED   1261 
COMPLETED   1187 
NOT COMPLETED   74 
Screening failures                7 
Protocol Violation                8 
Missing BPI Response                7 
Site closure                52 



  Baseline Characteristics

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
Participants With Adequate Pain Relief Adequate pain relief was defined as an average pain score of <=4 on the Brief Pain Inventory (BPI). Baseline characteristics are only reported for participants with data available at baseline.
Participants With Inadequate Pain Relief Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
Total Total of all reporting groups

Baseline Measures
   Participants With Adequate Pain Relief   Participants With Inadequate Pain Relief   Total 
Overall Participants Analyzed 
[Units: Participants]
 548   639   1187 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.6  (9.03)   68.0  (9.76)   67.8  (9.43) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      329  60.0%      479  75.0%      808  68.1% 
Male      219  40.0%      160  25.0%      379  31.9% 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline   [ Time Frame: Baseline (Day 1) ]

2.  Primary:   Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12   [ Time Frame: Month 12 ]

3.  Secondary:   Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)   [ Time Frame: Baseline (Day 1) ]

4.  Secondary:   Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1   [ Time Frame: Month 1 ]

5.  Secondary:   Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3   [ Time Frame: Month 3 ]

6.  Secondary:   Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6   [ Time Frame: Month 6 ]

7.  Secondary:   Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9   [ Time Frame: Month 9 ]

8.  Secondary:   Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12   [ Time Frame: Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Vice President, Late Stage Group Development Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01294696     History of Changes
Other Study ID Numbers: 0663-140
First Submitted: December 22, 2010
First Posted: February 11, 2011
Results First Submitted: January 21, 2014
Results First Posted: March 4, 2014
Last Update Posted: April 4, 2017