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

Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00619177
First received: February 8, 2008
Last updated: May 11, 2012
Last verified: May 2012
Results First Received: May 22, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Osteoarthritis
Arthritis, Rheumatoid

  Participant Flow
  Hide Participant Flow

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

Number of patients:

  • treated set = 3569 (treated with Movalis)
  • full analysis set = 3474 (patients completed 2 visits and had baseline and final 12-item Short-Form Health Survey (SF12) score)

Reporting Groups
  Description
Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection No text entered.

Participant Flow:   Overall Study
    Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection  
STARTED     3569 [1]
COMPLETED     3559 [2]
NOT COMPLETED     10  
Adverse Event                 2  
Lost to Follow-up                 2  
Not specified reasons                 6  
[1] treated set = 3569 (treated with Movalis)
[2] full analysis set = 3474 (patients completed 2 visits and had baseline and final SF12 score)



  Baseline Characteristics
  Hide 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
Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection No text entered.

Baseline Measures
    Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection  
Number of Participants  
[units: participants]
  3569  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 13.8  
Gender, Customized  
[units: participants]
 
Female     2355  
Male     1167  
Missing     47  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.   [ Time Frame: baseline and final visit (approximaly 4 weeks) ]

2.  Primary:   Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2   [ Time Frame: Baseline and final visit (approximately 4 weeks) ]

3.  Secondary:   Change From Baseline of Pain Intensity on Visual Analogue Scale   [ Time Frame: Approximately four weeks of treatment ]

4.  Secondary:   Patient Assessment of Efficacy   [ Time Frame: after approximately 4 weeks of treatment ]

5.  Secondary:   Physician Assessment of Efficacy   [ Time Frame: after approximately 4 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00619177     History of Changes
Other Study ID Numbers: 107.273
Study First Received: February 8, 2008
Results First Received: May 22, 2009
Last Updated: May 11, 2012
Health Authority: Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Estonia: State Agency of Medicines, EE-5041Tartu
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26