Assessing the Impact of MOVALIS in Osteoarthritis and Rhe... | NCT00619177

NCT00619177

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

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Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.	Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)	baseline and final visit (approximately 4 weeks)
Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2	Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)	Baseline and final visit (approximately 4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline of Pain Intensity on Visual Analogue Scale	The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain)	Approximately four weeks of treatment

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Split			Croatia
Boehringer Ingelheim Investigational Site

References Module

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IPD Sharing Statement Module

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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

Intervention Browse Module

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Masking Info

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FG0003569 subjectstreated set = 3569 (treated with Movalis)

Arm/Group Information

ID	Title	Description
BG000	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00011.2± 9.5

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

Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)

Posted

Mean

Standard Deviation

Units on a scale

Baseline and final visit (approximately 4 weeks)

ID	Title	Description
OG000	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician

Units	Counts
Participants	OG000

Secondary

Change From Baseline of Pain Intensity on Visual Analogue Scale

The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain)

Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on pain intensity on VAS at baseline and final visit.

Posted

Mean

Standard Deviation

Units on a scale

Approximately four weeks of treatment

ID	Title	Description
OG000	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician

Units	Counts
Participants	OG000

Secondary

Patient Assessment of Efficacy

Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.

The patients have been placed into categories according to the points on a scale.

Full analysis set (FAS). This analysis was performed on all patients in FAS with available data on the global assessment of general efficacy.

Posted

Number

Participants

after approximately 4 weeks of treatment

ID	Title	Description
OG000	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician

Units	Counts
Participants	OG000

Secondary

Physician Assessment of Efficacy

Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.

The patients have been placed into categories according to the points on a scale.

Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on physician assessment of efficacy.

Posted

Number

Participants

after approximately 4 weeks of treatment

ID	Title	Description
OG000	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician			0	3,569	0	3,569

ID	Term
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases