Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00619177
Collaborator
(none)
3,569
320
11.2
Study Details
Study Description
Brief Summary
The objective of the observational study is to examine the effect of MOVALIS (Meloxicam) therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2 (SF-12v2) will be used as the instrument to measure any change in physical wellbeing (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of patients following MOVALIS (Meloxicam) therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
3569 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessing the Impact of MOVALIS on Health Related Quality of Life
Study Start Date
:
Mar 1, 2007
Actual Primary Completion Date
:
May 1, 2008
Outcome Measures
Primary Outcome Measures
- Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit. [baseline and final visit (approximately 4 weeks)]
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)
- Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2 [Baseline and final visit (approximately 4 weeks)]
Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)
Secondary Outcome Measures
- Change From Baseline of Pain Intensity on Visual Analogue Scale [Approximately four weeks of treatment]
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)
- Patient Assessment of Efficacy [after approximately 4 weeks of treatment]
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.
- Physician Assessment of Efficacy [after approximately 4 weeks of treatment]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria (according to Summary of Product Characteristics (SPC) ):
- Male or female patients aged 18 years or above 2 Females of child bearing age must be using adequate contraception (hormonal or barrier method of birth control) 3. Patients with symptoms of acute, painful osteoarthritis or rheumatoid arthritis 4. Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs) 5. Patients requiring either parenteral and/or oral NSAIDs 6. Patients who have not taken another NSAID or Cyclo-oxygenase-2 (COX-2) inhibitor in the previous 7 days Pain intensity on the visual analogue scale (VAS) 25 mm and above
Exclusion Criteria (according to contraindications of Summary of Product Characteristics (SPC) ):
-
Known hypersensitivity to meloxicam or any excipient of the product, known or suspected hypersensitivity to analgesics, antipyretics or NSAIDs
-
Patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs
-
Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months
-
Severe liver failure
-
Non-dialysed severe renal failure
-
Pregnancy or breastfeeding
-
Haemostasis disorders or concomitant treatment with anticoagulants
-
Severe congestive heart failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim Investigational Site | Split | Croatia | ||
| 2 | Boehringer Ingelheim Investigational Site | Zagreb | Croatia | ||
| 3 | Boehringer Ingelheim Investigational Site | As | Czech Republic | ||
| 4 | Boehringer Ingelheim Investigational Site | Babice | Czech Republic | ||
| 5 | Boehringer Ingelheim Investigational Site | Benesov nad Ploucnicí | Czech Republic | ||
| 6 | Boehringer Ingelheim Investigational Site | Benesov u Prahy | Czech Republic | ||
| 7 | Boehringer Ingelheim Investigational Site | Benesov | Czech Republic | ||
| 8 | Boehringer Ingelheim Investigational Site | Benátky nad Jizerou | Czech Republic | ||
| 9 | Boehringer Ingelheim Investigational Site | Beroun | Czech Republic | ||
| 10 | Boehringer Ingelheim Investigational Site | Blansko | Czech Republic | ||
| 11 | Boehringer Ingelheim Investigational Site | Blatnice pod svatým Antonínkem | Czech Republic | ||
| 12 | Boehringer Ingelheim Investigational Site | Bohusovice nad Ohrí | Czech Republic | ||
| 13 | Boehringer Ingelheim Investigational Site | Bolatice | Czech Republic | ||
| 14 | Boehringer Ingelheim Investigational Site | Boskovice | Czech Republic | ||
| 15 | Boehringer Ingelheim Investigational Site | Bratríkov | Czech Republic | ||
| 16 | Boehringer Ingelheim Investigational Site | Breclav | Czech Republic | ||
| 17 | Boehringer Ingelheim Investigational Site | Brno | Czech Republic | ||
| 18 | Boehringer Ingelheim Investigational Site | Broumov | Czech Republic | ||
| 19 | Boehringer Ingelheim Investigational Site | Bruntál | Czech Republic | ||
| 20 | Boehringer Ingelheim Investigational Site | Buchlovice | Czech Republic | ||
| 21 | Boehringer Ingelheim Investigational Site | Bysice | Czech Republic | ||
| 22 | Boehringer Ingelheim Investigational Site | Bystrice nad Pernstejnem | Czech Republic | ||
| 23 | Boehringer Ingelheim Investigational Site | Bílina | Czech Republic | ||
| 24 | Boehringer Ingelheim Investigational Site | Bílovec | Czech Republic | ||
| 25 | Boehringer Ingelheim Investigational Site | Bílovice nad Svitavou | Czech Republic | ||
| 26 | Boehringer Ingelheim Investigational Site | Cernosice | Czech Republic | ||
| 27 | Boehringer Ingelheim Investigational Site | Cernozice | Czech Republic | ||
| 28 | Boehringer Ingelheim Investigational Site | Ceská Lípa | Czech Republic | ||
| 29 | Boehringer Ingelheim Investigational Site | Ceská Trebová | Czech Republic | ||
| 30 | Boehringer Ingelheim Investigational Site | Ceské Budojovice | Czech Republic | ||
| 31 | Boehringer Ingelheim Investigational Site | Ceský Tesín | Czech Republic | ||
| 32 | Boehringer Ingelheim Investigational Site | Cheb | Czech Republic | ||
| 33 | Boehringer Ingelheim Investigational Site | Chodov | Czech Republic | ||
| 34 | Boehringer Ingelheim Investigational Site | Chomutov | Czech Republic | ||
| 35 | Boehringer Ingelheim Investigational Site | Chropyne | Czech Republic | ||
| 36 | Boehringer Ingelheim Investigational Site | Chrudim | Czech Republic | ||
| 37 | Boehringer Ingelheim Investigational Site | Cáslav | Czech Republic | ||
| 38 | Boehringer Ingelheim Investigational Site | Decín | Czech Republic | ||
| 39 | Boehringer Ingelheim Investigational Site | Dobrany | Czech Republic | ||
| 40 | Boehringer Ingelheim Investigational Site | Dobruska | Czech Republic | ||
| 41 | Boehringer Ingelheim Investigational Site | Dobrís | Czech Republic | ||
| 42 | Boehringer Ingelheim Investigational Site | Dol . Lou. | Czech Republic | ||
| 43 | Boehringer Ingelheim Investigational Site | Dolní Benesov | Czech Republic | ||
| 44 | Boehringer Ingelheim Investigational Site | Dolní Berkovice | Czech Republic | ||
| 45 | Boehringer Ingelheim Investigational Site | Domazlice | Czech Republic | ||
| 46 | Boehringer Ingelheim Investigational Site | Drnovice | Czech Republic | ||
| 47 | Boehringer Ingelheim Investigational Site | Dvur Králové nad Labem | Czech Republic | ||
| 48 | Boehringer Ingelheim Investigational Site | Frenstát | Czech Republic | ||
| 49 | Boehringer Ingelheim Investigational Site | Frýdek-Místek | Czech Republic | ||
| 50 | Boehringer Ingelheim Investigational Site | Frýdlant | Czech Republic | ||
| 51 | Boehringer Ingelheim Investigational Site | Fulnek | Czech Republic | ||
| 52 | Boehringer Ingelheim Investigational Site | Hanusovice | Czech Republic | ||
| 53 | Boehringer Ingelheim Investigational Site | Havlíckuv Brod | Czech Republic | ||
| 54 | Boehringer Ingelheim Investigational Site | Havírov | Czech Republic | ||
| 55 | Boehringer Ingelheim Investigational Site | Hermanuv Mestec | Czech Republic | ||
| 56 | Boehringer Ingelheim Investigational Site | Hlucín | Czech Republic | ||
| 57 | Boehringer Ingelheim Investigational Site | Hluk | Czech Republic | ||
| 58 | Boehringer Ingelheim Investigational Site | Hodonice | Czech Republic | ||
| 59 | Boehringer Ingelheim Investigational Site | Hodonín | Czech Republic | ||
| 60 | Boehringer Ingelheim Investigational Site | Holesov | Czech Republic | ||
| 61 | Boehringer Ingelheim Investigational Site | Holice | Czech Republic | ||
| 62 | Boehringer Ingelheim Investigational Site | Horice v Podkrkonosí | Czech Republic | ||
| 63 | Boehringer Ingelheim Investigational Site | Horní Berkovice | Czech Republic | ||
| 64 | Boehringer Ingelheim Investigational Site | Horní Slavkov | Czech Republic | ||
| 65 | Boehringer Ingelheim Investigational Site | Horovice | Czech Republic | ||
| 66 | Boehringer Ingelheim Investigational Site | Hostinné | Czech Republic | ||
| 67 | Boehringer Ingelheim Investigational Site | Hostka | Czech Republic | ||
| 68 | Boehringer Ingelheim Investigational Site | Hradec Králové | Czech Republic | ||
| 69 | Boehringer Ingelheim Investigational Site | Hronov | Czech Republic | ||
| 70 | Boehringer Ingelheim Investigational Site | Hrusovany nad Jevisovkou | Czech Republic | ||
| 71 | Boehringer Ingelheim Investigational Site | Hrádek n.N. | Czech Republic | ||
| 72 | Boehringer Ingelheim Investigational Site | Hulín | Czech Republic | ||
| 73 | Boehringer Ingelheim Investigational Site | Hustopece u Brna | Czech Republic | ||
| 74 | Boehringer Ingelheim Investigational Site | Hustopece | Czech Republic | ||
| 75 | Boehringer Ingelheim Investigational Site | Jablonec n.N. | Czech Republic | ||
| 76 | Boehringer Ingelheim Investigational Site | Jablonec | Czech Republic | ||
| 77 | Boehringer Ingelheim Investigational Site | Jablunkov | Czech Republic | ||
| 78 | Boehringer Ingelheim Investigational Site | Jaromer | Czech Republic | ||
| 79 | Boehringer Ingelheim Investigational Site | Javorník | Czech Republic | ||
| 80 | Boehringer Ingelheim Investigational Site | Jeseník | Czech Republic | ||
| 81 | Boehringer Ingelheim Investigational Site | Jicín | Czech Republic | ||
| 82 | Boehringer Ingelheim Investigational Site | Jihlava | Czech Republic | ||
| 83 | Boehringer Ingelheim Investigational Site | Jirkov | Czech Republic | ||
| 84 | Boehringer Ingelheim Investigational Site | Kadan | Czech Republic | ||
| 85 | Boehringer Ingelheim Investigational Site | Kaplice | Czech Republic | ||
| 86 | Boehringer Ingelheim Investigational Site | Karlovy Vary | Czech Republic | ||
| 87 | Boehringer Ingelheim Investigational Site | Karviná | Czech Republic | ||
| 88 | Boehringer Ingelheim Investigational Site | Kladno | Czech Republic | ||
| 89 | Boehringer Ingelheim Investigational Site | Klatovy | Czech Republic | ||
| 90 | Boehringer Ingelheim Investigational Site | Klobouky | Czech Republic | ||
| 91 | Boehringer Ingelheim Investigational Site | Klásterec n. Ohrí | Czech Republic | ||
| 92 | Boehringer Ingelheim Investigational Site | Kolín | Czech Republic | ||
| 93 | Boehringer Ingelheim Investigational Site | Konice | Czech Republic | ||
| 94 | Boehringer Ingelheim Investigational Site | Koprivnice | Czech Republic | ||
| 95 | Boehringer Ingelheim Investigational Site | Kosmonosy | Czech Republic | ||
| 96 | Boehringer Ingelheim Investigational Site | Kostelec nad Orlicí | Czech Republic | ||
| 97 | Boehringer Ingelheim Investigational Site | Kralupy nad Vltavou | Czech Republic | ||
| 98 | Boehringer Ingelheim Investigational Site | Krnov | Czech Republic | ||
| 99 | Boehringer Ingelheim Investigational Site | Kromeríz | Czech Republic | ||
| 100 | Boehringer Ingelheim Investigational Site | Krouna | Czech Republic | ||
| 101 | Boehringer Ingelheim Investigational Site | Krupka | Czech Republic | ||
| 102 | Boehringer Ingelheim Investigational Site | Králuv Dvur | Czech Republic | ||
| 103 | Boehringer Ingelheim Investigational Site | Kunovice | Czech Republic | ||
| 104 | Boehringer Ingelheim Investigational Site | Kurim | Czech Republic | ||
| 105 | Boehringer Ingelheim Investigational Site | Kyjov | Czech Republic | ||
| 106 | Boehringer Ingelheim Investigational Site | Lanskroun | Czech Republic | ||
| 107 | Boehringer Ingelheim Investigational Site | Ledec nad Sázavou | Czech Republic | ||
| 108 | Boehringer Ingelheim Investigational Site | Lenesice | Czech Republic | ||
| 109 | Boehringer Ingelheim Investigational Site | Letohrad | Czech Republic | ||
| 110 | Boehringer Ingelheim Investigational Site | Liberec | Czech Republic | ||
| 111 | Boehringer Ingelheim Investigational Site | Libesice | Czech Republic | ||
| 112 | Boehringer Ingelheim Investigational Site | Libochovice | Czech Republic | ||
| 113 | Boehringer Ingelheim Investigational Site | Lipová Lázne | Czech Republic | ||
| 114 | Boehringer Ingelheim Investigational Site | Litomerice | Czech Republic | ||
| 115 | Boehringer Ingelheim Investigational Site | Litovel | Czech Republic | ||
| 116 | Boehringer Ingelheim Investigational Site | Litvínov | Czech Republic | ||
| 117 | Boehringer Ingelheim Investigational Site | Lomnice n.P. | Czech Republic | ||
| 118 | Boehringer Ingelheim Investigational Site | Louny | Czech Republic | ||
| 119 | Boehringer Ingelheim Investigational Site | Lovosice | Czech Republic | ||
| 120 | Boehringer Ingelheim Investigational Site | Ludgérovice | Czech Republic | ||
| 121 | Boehringer Ingelheim Investigational Site | Mariánské Lázne | Czech Republic | ||
| 122 | Boehringer Ingelheim Investigational Site | Melník | Czech Republic | ||
| 123 | Boehringer Ingelheim Investigational Site | Mesto Albrechtice | Czech Republic | ||
| 124 | Boehringer Ingelheim Investigational Site | Milovice | Czech Republic | ||
| 125 | Boehringer Ingelheim Investigational Site | Milín | Czech Republic | ||
| 126 | Boehringer Ingelheim Investigational Site | Mladá Boleslav | Czech Republic | ||
| 127 | Boehringer Ingelheim Investigational Site | Mlázovice | Czech Republic | ||
| 128 | Boehringer Ingelheim Investigational Site | Mnísek pod Brdy | Czech Republic | ||
| 129 | Boehringer Ingelheim Investigational Site | Modrice | Czech Republic | ||
| 130 | Boehringer Ingelheim Investigational Site | Mohelnice | Czech Republic | ||
| 131 | Boehringer Ingelheim Investigational Site | Mor.Budejovice | Czech Republic | ||
| 132 | Boehringer Ingelheim Investigational Site | Mor.Krumlov | Czech Republic | ||
| 133 | Boehringer Ingelheim Investigational Site | Mor.Nová Ves | Czech Republic | ||
| 134 | Boehringer Ingelheim Investigational Site | Moravany | Czech Republic | ||
| 135 | Boehringer Ingelheim Investigational Site | Most | Czech Republic | ||
| 136 | Boehringer Ingelheim Investigational Site | Míretice | Czech Republic | ||
| 137 | Boehringer Ingelheim Investigational Site | Mýto | Czech Republic | ||
| 138 | Boehringer Ingelheim Investigational Site | Nasavrky | Czech Republic | ||
| 139 | Boehringer Ingelheim Investigational Site | Nechanice | Czech Republic | ||
| 140 | Boehringer Ingelheim Investigational Site | Neratovice | Czech Republic | ||
| 141 | Boehringer Ingelheim Investigational Site | Nová Ves pod Plesí | Czech Republic | ||
| 142 | Boehringer Ingelheim Investigational Site | Nové Mesto nad Metují | Czech Republic | ||
| 143 | Boehringer Ingelheim Investigational Site | Nový Bor | Czech Republic | ||
| 144 | Boehringer Ingelheim Investigational Site | Nový Bydzov | Czech Republic | ||
| 145 | Boehringer Ingelheim Investigational Site | Nový Jicín | Czech Republic | ||
| 146 | Boehringer Ingelheim Investigational Site | Nový Knín | Czech Republic | ||
| 147 | Boehringer Ingelheim Investigational Site | Nymburk | Czech Republic | ||
| 148 | Boehringer Ingelheim Investigational Site | Náchod | Czech Republic | ||
| 149 | Boehringer Ingelheim Investigational Site | Námest nad Oslavou | Czech Republic | ||
| 150 | Boehringer Ingelheim Investigational Site | Obratan | Czech Republic | ||
| 151 | Boehringer Ingelheim Investigational Site | Obríství | Czech Republic | ||
| 152 | Boehringer Ingelheim Investigational Site | Olomouc | Czech Republic | ||
| 153 | Boehringer Ingelheim Investigational Site | Opava | Czech Republic | ||
| 154 | Boehringer Ingelheim Investigational Site | Opocno | Czech Republic | ||
| 155 | Boehringer Ingelheim Investigational Site | Orlová | Czech Republic | ||
| 156 | Boehringer Ingelheim Investigational Site | Ostrava | Czech Republic | ||
| 157 | Boehringer Ingelheim Investigational Site | Otrokovice | Czech Republic | ||
| 158 | Boehringer Ingelheim Investigational Site | Pacov | Czech Republic | ||
| 159 | Boehringer Ingelheim Investigational Site | Pardubice | Czech Republic | ||
| 160 | Boehringer Ingelheim Investigational Site | Pelhrimov | Czech Republic | ||
| 161 | Boehringer Ingelheim Investigational Site | Petrvald | Czech Republic | ||
| 162 | Boehringer Ingelheim Investigational Site | Pierov | Czech Republic | ||
| 163 | Boehringer Ingelheim Investigational Site | Planá | Czech Republic | ||
| 164 | Boehringer Ingelheim Investigational Site | Plzen | Czech Republic | ||
| 165 | Boehringer Ingelheim Investigational Site | Polná | Czech Republic | ||
| 166 | Boehringer Ingelheim Investigational Site | Postoloprty | Czech Republic | ||
| 167 | Boehringer Ingelheim Investigational Site | Postrelmov | Czech Republic | ||
| 168 | Boehringer Ingelheim Investigational Site | Prachatice | Czech Republic | ||
| 169 | Boehringer Ingelheim Investigational Site | Praha | Czech Republic | ||
| 170 | Boehringer Ingelheim Investigational Site | Prelouc | Czech Republic | ||
| 171 | Boehringer Ingelheim Investigational Site | Prestice | Czech Republic | ||
| 172 | Boehringer Ingelheim Investigational Site | Prostejov | Czech Republic | ||
| 173 | Boehringer Ingelheim Investigational Site | Príbram | Czech Republic | ||
| 174 | Boehringer Ingelheim Investigational Site | Písek | Czech Republic | ||
| 175 | Boehringer Ingelheim Investigational Site | Radonice | Czech Republic | ||
| 176 | Boehringer Ingelheim Investigational Site | Rakovník | Czech Republic | ||
| 177 | Boehringer Ingelheim Investigational Site | Raspenava | Czech Republic | ||
| 178 | Boehringer Ingelheim Investigational Site | Revnice | Czech Republic | ||
| 179 | Boehringer Ingelheim Investigational Site | Rokycany | Czech Republic | ||
| 180 | Boehringer Ingelheim Investigational Site | Roudnice nad Labem | Czech Republic | ||
| 181 | Boehringer Ingelheim Investigational Site | Roznov pod Radhostem | Czech Republic | ||
| 182 | Boehringer Ingelheim Investigational Site | Ruda nad Moravou | Czech Republic | ||
| 183 | Boehringer Ingelheim Investigational Site | Rudná u Prahy | Czech Republic | ||
| 184 | Boehringer Ingelheim Investigational Site | Rumburk | Czech Republic | ||
| 185 | Boehringer Ingelheim Investigational Site | Rychnov nad Kneznou | Czech Republic | ||
| 186 | Boehringer Ingelheim Investigational Site | Rícany u Brna | Czech Republic | ||
| 187 | Boehringer Ingelheim Investigational Site | Rýmarov | Czech Republic | ||
| 188 | Boehringer Ingelheim Investigational Site | Saratice | Czech Republic | ||
| 189 | Boehringer Ingelheim Investigational Site | Semily | Czech Republic | ||
| 190 | Boehringer Ingelheim Investigational Site | Senov u NJ | Czech Republic | ||
| 191 | Boehringer Ingelheim Investigational Site | Skutec | Czech Republic | ||
| 192 | Boehringer Ingelheim Investigational Site | Slaný | Czech Republic | ||
| 193 | Boehringer Ingelheim Investigational Site | Slatinany | Czech Republic | ||
| 194 | Boehringer Ingelheim Investigational Site | Slavicín | Czech Republic | ||
| 195 | Boehringer Ingelheim Investigational Site | Slusovice | Czech Republic | ||
| 196 | Boehringer Ingelheim Investigational Site | Smidary | Czech Republic | ||
| 197 | Boehringer Ingelheim Investigational Site | Smirice | Czech Republic | ||
| 198 | Boehringer Ingelheim Investigational Site | Sokolov | Czech Republic | ||
| 199 | Boehringer Ingelheim Investigational Site | Spálené Porící | Czech Republic | ||
| 200 | Boehringer Ingelheim Investigational Site | Staré Mesto | Czech Republic | ||
| 201 | Boehringer Ingelheim Investigational Site | Starý Plzenec | Czech Republic | ||
| 202 | Boehringer Ingelheim Investigational Site | Stenovice | Czech Republic | ||
| 203 | Boehringer Ingelheim Investigational Site | Stetí | Czech Republic | ||
| 204 | Boehringer Ingelheim Investigational Site | Strakonice | Czech Republic | ||
| 205 | Boehringer Ingelheim Investigational Site | Stríbro | Czech Republic | ||
| 206 | Boehringer Ingelheim Investigational Site | Studená | Czech Republic | ||
| 207 | Boehringer Ingelheim Investigational Site | Studénka | Czech Republic | ||
| 208 | Boehringer Ingelheim Investigational Site | Stáhlavy | Czech Republic | ||
| 209 | Boehringer Ingelheim Investigational Site | Sumperk | Czech Republic | ||
| 210 | Boehringer Ingelheim Investigational Site | Svetlá nad Sázavou | Czech Republic | ||
| 211 | Boehringer Ingelheim Investigational Site | Teplice | Czech Republic | ||
| 212 | Boehringer Ingelheim Investigational Site | Tisnov | Czech Republic | ||
| 213 | Boehringer Ingelheim Investigational Site | Tlucná | Czech Republic | ||
| 214 | Boehringer Ingelheim Investigational Site | Touzim | Czech Republic | ||
| 215 | Boehringer Ingelheim Investigational Site | Trebíc | Czech Republic | ||
| 216 | Boehringer Ingelheim Investigational Site | Tremosná | Czech Republic | ||
| 217 | Boehringer Ingelheim Investigational Site | Trest | Czech Republic | ||
| 218 | Boehringer Ingelheim Investigational Site | Trinec | Czech Republic | ||
| 219 | Boehringer Ingelheim Investigational Site | Trutnov | Czech Republic | ||
| 220 | Boehringer Ingelheim Investigational Site | Tupesy | Czech Republic | ||
| 221 | Boehringer Ingelheim Investigational Site | Turnov | Czech Republic | ||
| 222 | Boehringer Ingelheim Investigational Site | Tábor | Czech Republic | ||
| 223 | Boehringer Ingelheim Investigational Site | Uherské Hradiste | Czech Republic | ||
| 224 | Boehringer Ingelheim Investigational Site | Uherský Brod | Czech Republic | ||
| 225 | Boehringer Ingelheim Investigational Site | Val.Bystrice | Czech Republic | ||
| 226 | Boehringer Ingelheim Investigational Site | Valasské Mezirící | Czech Republic | ||
| 227 | Boehringer Ingelheim Investigational Site | Vamberk | Czech Republic | ||
| 228 | Boehringer Ingelheim Investigational Site | Varnsdorf | Czech Republic | ||
| 229 | Boehringer Ingelheim Investigational Site | Velká Bítes | Czech Republic | ||
| 230 | Boehringer Ingelheim Investigational Site | Velké Mezirící | Czech Republic | ||
| 231 | Boehringer Ingelheim Investigational Site | Velké Opatovice | Czech Republic | ||
| 232 | Boehringer Ingelheim Investigational Site | Velké Porící | Czech Republic | ||
| 233 | Boehringer Ingelheim Investigational Site | Veselí nad Moravou | Czech Republic | ||
| 234 | Boehringer Ingelheim Investigational Site | Vintírov | Czech Republic | ||
| 235 | Boehringer Ingelheim Investigational Site | Vlasim | Czech Republic | ||
| 236 | Boehringer Ingelheim Investigational Site | Vodnany | Czech Republic | ||
| 237 | Boehringer Ingelheim Investigational Site | Votice | Czech Republic | ||
| 238 | Boehringer Ingelheim Investigational Site | Vrbno pod Pradedem | Czech Republic | ||
| 239 | Boehringer Ingelheim Investigational Site | Vsetín | Czech Republic | ||
| 240 | Boehringer Ingelheim Investigational Site | Vyskov | Czech Republic | ||
| 241 | Boehringer Ingelheim Investigational Site | Vysoké Mýto | Czech Republic | ||
| 242 | Boehringer Ingelheim Investigational Site | Vápenná | Czech Republic | ||
| 243 | Boehringer Ingelheim Investigational Site | Zamberk | Czech Republic | ||
| 244 | Boehringer Ingelheim Investigational Site | Zastávka u Brna | Czech Republic | ||
| 245 | Boehringer Ingelheim Investigational Site | Zatec | Czech Republic | ||
| 246 | Boehringer Ingelheim Investigational Site | Zbýsov | Czech Republic | ||
| 247 | Boehringer Ingelheim Investigational Site | Zdár nad Sázavou | Czech Republic | ||
| 248 | Boehringer Ingelheim Investigational Site | Zinkovy | Czech Republic | ||
| 249 | Boehringer Ingelheim Investigational Site | Zirovnice | Czech Republic | ||
| 250 | Boehringer Ingelheim Investigational Site | Zlín | Czech Republic | ||
| 251 | Boehringer Ingelheim Investigational Site | Znojmo | Czech Republic | ||
| 252 | Boehringer Ingelheim Investigational Site | Zábieh | Czech Republic | ||
| 253 | Boehringer Ingelheim Investigational Site | Ústek | Czech Republic | ||
| 254 | Boehringer Ingelheim Investigational Site | Ústí nad Labem | Czech Republic | ||
| 255 | Boehringer Ingelheim Investigational Site | Ústí nad Orlicí | Czech Republic | ||
| 256 | Boehringer Ingelheim Investigational Site | Elva | Estonia | ||
| 257 | Boehringer Ingelheim Investigational Site | Haapsalu | Estonia | ||
| 258 | Boehringer Ingelheim Investigational Site | Johvi | Estonia | ||
| 259 | Boehringer Ingelheim Investigational Site | Kohtla-Jarve | Estonia | ||
| 260 | Boehringer Ingelheim Investigational Site | Kose | Estonia | ||
| 261 | Boehringer Ingelheim Investigational Site | Laane-Virumaa | Estonia | ||
| 262 | Boehringer Ingelheim Investigational Site | Narva | Estonia | ||
| 263 | Boehringer Ingelheim Investigational Site | Paide | Estonia | ||
| 264 | Boehringer Ingelheim Investigational Site | Parne | Estonia | ||
| 265 | Boehringer Ingelheim Investigational Site | Polva | Estonia | ||
| 266 | Boehringer Ingelheim Investigational Site | Rakvere | Estonia | ||
| 267 | Boehringer Ingelheim Investigational Site | Sillamae | Estonia | ||
| 268 | Boehringer Ingelheim Investigational Site | Tallinn | Estonia | ||
| 269 | Boehringer Ingelheim Investigational Site | Tartu | Estonia | ||
| 270 | Boehringer Ingelheim Investigational Site | Viljandi | Estonia | ||
| 271 | Boehringer Ingelheim Investigational Site | Bryansk | Russian Federation | ||
| 272 | Boehringer Ingelheim Investigational Site | Dmitrov | Russian Federation | ||
| 273 | Boehringer Ingelheim Investigational Site | Dolgoprudnii | Russian Federation | ||
| 274 | Boehringer Ingelheim Investigational Site | Dzerzinsk | Russian Federation | ||
| 275 | Boehringer Ingelheim Investigational Site | Gukovscii | Russian Federation | ||
| 276 | Boehringer Ingelheim Investigational Site | Ivanovo | Russian Federation | ||
| 277 | Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 278 | Boehringer Ingelheim Investigational Site | Nijnii Novgorod | Russian Federation | ||
| 279 | Boehringer Ingelheim Investigational Site | Nizhni Novgorod | Russian Federation | ||
| 280 | Boehringer Ingelheim Investigational Site | Podolsk | Russian Federation | ||
| 281 | Boehringer Ingelheim Investigational Site | Ryazan | Russian Federation | ||
| 282 | Boehringer Ingelheim Investigational Site | Smolensk | Russian Federation | ||
| 283 | Boehringer Ingelheim Investigational Site | Vladimir | Russian Federation | ||
| 284 | Boehringer Ingelheim Investigational Site | Yaroslavl | Russian Federation | ||
| 285 | Boehringer Ingelheim Investigational Site | Bardejov | Slovakia | ||
| 286 | Boehringer Ingelheim Investigational Site | Bosany | Slovakia | ||
| 287 | Boehringer Ingelheim Investigational Site | Bran? | Slovakia | ||
| 288 | Boehringer Ingelheim Investigational Site | Bánovce/Bebravou | Slovakia | ||
| 289 | Boehringer Ingelheim Investigational Site | Handlová | Slovakia | ||
| 290 | Boehringer Ingelheim Investigational Site | Humenné | Slovakia | ||
| 291 | Boehringer Ingelheim Investigational Site | Kezmarok | Slovakia | ||
| 292 | Boehringer Ingelheim Investigational Site | Kluknava | Slovakia | ||
| 293 | Boehringer Ingelheim Investigational Site | Kosice | Slovakia | ||
| 294 | Boehringer Ingelheim Investigational Site | Krompachy | Slovakia | ||
| 295 | Boehringer Ingelheim Investigational Site | Liptovský Mikulás | Slovakia | ||
| 296 | Boehringer Ingelheim Investigational Site | Malacky | Slovakia | ||
| 297 | Boehringer Ingelheim Investigational Site | Martin | Slovakia | ||
| 298 | Boehringer Ingelheim Investigational Site | Michalovce | Slovakia | ||
| 299 | Boehringer Ingelheim Investigational Site | Nitra | Slovakia | ||
| 300 | Boehringer Ingelheim Investigational Site | Nove Mesto/Váhom | Slovakia | ||
| 301 | Boehringer Ingelheim Investigational Site | Námestovo | Slovakia | ||
| 302 | Boehringer Ingelheim Investigational Site | Pies?any | Slovakia | ||
| 303 | Boehringer Ingelheim Investigational Site | Poprad | Slovakia | ||
| 304 | Boehringer Ingelheim Investigational Site | Presov | Slovakia | ||
| 305 | Boehringer Ingelheim Investigational Site | Ruzomberok | Slovakia | ||
| 306 | Boehringer Ingelheim Investigational Site | Se?ovská Polianka | Slovakia | ||
| 307 | Boehringer Ingelheim Investigational Site | Senec | Slovakia | ||
| 308 | Boehringer Ingelheim Investigational Site | Spisská Nová Ves | Slovakia | ||
| 309 | Boehringer Ingelheim Investigational Site | St. ?ubov?a | Slovakia | ||
| 310 | Boehringer Ingelheim Investigational Site | Stará Turá | Slovakia | ||
| 311 | Boehringer Ingelheim Investigational Site | Stropkov | Slovakia | ||
| 312 | Boehringer Ingelheim Investigational Site | Svinia | Slovakia | ||
| 313 | Boehringer Ingelheim Investigational Site | Topo??any | Slovakia | ||
| 314 | Boehringer Ingelheim Investigational Site | Torna?a | Slovakia | ||
| 315 | Boehringer Ingelheim Investigational Site | Trebisov | Slovakia | ||
| 316 | Boehringer Ingelheim Investigational Site | Tren?ín | Slovakia | ||
| 317 | Boehringer Ingelheim Investigational Site | Trhoviste | Slovakia | ||
| 318 | Boehringer Ingelheim Investigational Site | Vranov/Top?ou | Slovakia | ||
| 319 | Boehringer Ingelheim Investigational Site | Vrútky | Slovakia | ||
| 320 | Boehringer Ingelheim Investigational Site | Zilina | Slovakia |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00619177
Other Study ID Numbers:
- 107.273
First Posted:
Feb 20, 2008
Last Update Posted:
Feb 16, 2015
Last Verified:
Jan 1, 2015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Number of patients: treated set = 3569 (treated with Movalis) full analysis set = 3473 (patients completed 2 visits and had baseline and final 12-item Short-Form Health Survey (SF12) score) |
| Arm/Group Title | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection |
|---|---|
| Arm/Group Description | 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician |
| Period Title: Overall Study | |
| STARTED | 3569 |
| COMPLETED | 3061 |
| NOT COMPLETED | 508 |
Baseline Characteristics
| Arm/Group Title | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection |
|---|---|
| Arm/Group Description | 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician |
| Overall Participants | 3569 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
57
(13.8)
|
| Sex/Gender, Customized (participants) [Number] | |
| Female |
2355
66%
|
| Male |
1167
32.7%
|
| Missing |
47
1.3%
|
Outcome Measures
| Title | Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit. |
|---|---|
| Description | 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) |
| Time Frame | baseline and final visit (approximately 4 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS). |
| Arm/Group Title | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection |
|---|---|
| Arm/Group Description | 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician |
| Measure Participants | 3473 |
| Mean (Standard Deviation) [Units on a scale] |
11.2
(9.5)
|
| Title | Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2 |
|---|---|
| Description | Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing) |
| Time Frame | Baseline and final visit (approximately 4 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS). |
| Arm/Group Title | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection |
|---|---|
| Arm/Group Description | 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician |
| Measure Participants | 3473 |
| Mean (Standard Deviation) [Units on a scale] |
6.2
(10.1)
|
| Title | Change From Baseline of Pain Intensity on Visual Analogue Scale |
|---|---|
| Description | 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) |
| Time Frame | Approximately four weeks of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection |
|---|---|
| Arm/Group Description | 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician |
| Measure Participants | 3459 |
| Mean (Standard Deviation) [Units on a scale] |
41.9
(18.9)
|
| Title | Patient Assessment of Efficacy |
|---|---|
| Description | 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. |
| Time Frame | after approximately 4 weeks of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS). This analysis was performed on all patients in FAS with available data on the global assessment of general efficacy. |
| Arm/Group Title | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection |
|---|---|
| Arm/Group Description | 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician |
| Measure Participants | 3461 |
| Excellent |
803
22.5%
|
| Very Good |
1540
43.1%
|
| Good |
928
26%
|
| Fair |
161
4.5%
|
| Poor |
29
0.8%
|
| Title | Physician Assessment of Efficacy |
|---|---|
| Description | 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. |
| Time Frame | after approximately 4 weeks of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on physician assessment of efficacy. |
| Arm/Group Title | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection |
|---|---|
| Arm/Group Description | 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician |
| Measure Participants | 3467 |
| Excellent |
879
24.6%
|
| Very Good |
1652
46.3%
|
| Good |
806
22.6%
|
| Fair |
109
3.1%
|
| Poor |
21
0.6%
|
Adverse Events
| Time Frame | 4 weeks + 5 days | |
|---|---|---|
| Adverse Event Reporting Description | There were no serious adverse events (SAEs) nor AEs over 5% frequency reported | |
| Arm/Group Title | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | |
| Arm/Group Description | 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician | |
All Cause Mortality |
||
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3569 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3569 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00619177
Other Study ID Numbers:
- 107.273
First Posted:
Feb 20, 2008
Last Update Posted:
Feb 16, 2015
Last Verified:
Jan 1, 2015