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 Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00619177

First received: February 8, 2008

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Results First Received: May 22, 2009

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Osteoarthritis Arthritis, Rheumatoid

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
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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)

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

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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

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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) ]

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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) ]

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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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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

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