Knee Osteoarthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Comparative Parallel Group Study of Analgesic Effectiveness and Safety of Three Different Doses of Lamaline® New Formulation vs Dafalgan® Codeine, After 10 Days Administration in Subjects With Painful Gonarthrosis.
This study aims to assess the analgesic effectiveness and safety of three different doses of a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in subjects with painful gonarthrosis
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - History of knee (unilateral or bilateral) osteoarthritis for at least 6 months - Pain intensity assessed by Visual Analogue Scale = 40 mm - Partial functional disability assessed by Lequesne index =4 and < than 12 Exclusion Criteria: - Patient unable to interrupt his/her NSAIDs to participate in the clinical study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Site 2 | Albi | |
| France | Site 3 | Andernos Les Bains | |
| France | Site 101 | Angers | |
| France | Site 103 | Angers | |
| France | Site 105 | Angers | |
| France | Site 106 | Angers | |
| France | Site 107 | Angers | |
| France | Site 108 | Angers | |
| France | Site 109 | Angers | |
| France | Site 110 | Angers | |
| France | Site 117 | Angers | |
| France | Site 121 | Angers | |
| France | Site 123 | Angers | |
| France | Site 124 | Angers | |
| France | Site 129 | Angers | |
| France | Site 134 | Angers | |
| France | Site 138 | Angers | |
| France | Site 140 | Angers | |
| France | Site 453 | Angers | |
| France | Site 496 | Angers | |
| France | Site 498 | Angers | |
| France | Site 215 | Anzin | |
| France | Site 451 | Avrille | |
| France | Site 131 | Bagneux | |
| France | Site 315 | Bandol | |
| France | Site 4 | Bassens | |
| France | Site 115 | Beaucouze | |
| France | Site 502 | Beaumont Sur Leze | |
| France | Site 449 | Beaupreau | |
| France | Site 119 | Becon Les Granits | |
| France | Site 135 | Becon Les Granits | |
| France | Site 136 | Becon Les Granits | |
| France | Site 506 | Berat | |
| France | Site 213 | Bersee | |
| France | Site 50 | Beziers | |
| France | Site 55 | Beziers | |
| France | Site 5 | Bobigny | |
| France | Site 6 | Bordeaux | |
| France | Site 122 | Briollay | |
| France | Site 7 | Brive La Gaillarde | |
| France | Site 8 | Carpentras | |
| France | Site 76 | Chalons En Champagne | |
| France | Site 9 | Chalons En Champagne | |
| France | Site 432 | Chateau-Gontier | |
| France | Site 433 | Chateau-Gontier | |
| France | Site 48 | Chatenay Malabry | |
| France | Site 114 | Chemille | |
| France | Site 462 | Cherbourg | |
| France | Site 10 | Clamart | |
| France | Site 11 | Clermont Ferrand | |
| France | Site 12 | Clermont Ferrand | |
| France | Site 13 | Clermont Ferrand | |
| France | Site 14 | Colmar | |
| France | Site 78 | Colmar | |
| France | Site 219 | Croix | |
| France | Site 15 | Dijon | |
| France | Site 16 | Dinan | |
| France | Site 17 | Dinard | |
| France | Site 47 | Dinard | |
| France | Site 507 | Eaunes | |
| France | Site 120 | Ecouflant | |
| France | Site 18 | Evreux | |
| France | Site 19 | Evreux | |
| France | Site 46 | Evreux | |
| France | Site 102 | Fenioux | |
| France | Site 20 | Fontenay Malabry | |
| France | Site 24 | L'union | |
| France | Site 306 | La Garde | |
| France | Site 207 | La Riche | |
| France | Site 209 | La Riche | |
| France | Site 423 | La Rochelle | |
| France | Site 318 | La Seyne Sur Mer | |
| France | Site 319 | La Seyne Sur Mer | |
| France | Site 320 | La Seyne Sur Mer | |
| France | Site 321 | La Seyne Sur Mer | |
| France | Site 454 | Laval | |
| France | Site 458 | Laval | |
| France | Site 459 | Laval | |
| France | Site 460 | Laval | |
| France | Site 461 | Laval | |
| France | Site 224 | Le Pradet | |
| France | Site 225 | Le Pradet | |
| France | Site 118 | Les Ponts de Ce | |
| France | Site 137 | Les Ponts de Ce | |
| France | Site 21 | Levallois Perret | |
| France | Site 22 | Libourne | |
| France | Site 23 | Limoges | |
| France | Site 49 | Lyon | |
| France | Site 53 | Lyon | |
| France | Site 58 | Lyon | |
| France | Site 59 | Lyon | |
| France | Site 64 | Lyon | |
| France | Site 25 | Marseille | |
| France | Site 26 | Marseille | |
| France | Site 27 | Marseille | |
| France | Site 28 | Marseille | |
| France | Site 77 | Marseille | |
| France | Site 29 | Merignac | |
| France | Site 70 | Millau | |
| France | Site 56 | Montpellier | |
| France | Site 60 | Montpellier | |
| France | Site 62 | Montpellier | |
| France | Site 65 | Montpellier | |
| France | Site 68 | Montpellier | |
| France | Site 139 | Montreuil Bellay | |
| France | Site 133 | Montrevault | |
| France | Site 30 | Montrouge | |
| France | Site 51 | Nice | |
| France | Site 54 | Nice | |
| France | Site 57 | Nice | |
| France | Site 61 | Nice | |
| France | Site 71 | Nice | |
| France | Site 74 | Nice | |
| France | Site 63 | Nimes | |
| France | Site 67 | Nimes | |
| France | Site 69 | Nimes | |
| France | Site 73 | Nimes | |
| France | Site 130 | Noyant | |
| France | Site 128 | Parcay Les Pins | |
| France | Site 31 | Paris | |
| France | Site 32 | Paris | |
| France | Site 66 | Perpignan | |
| France | Site 33 | Pont de L'arche | |
| France | Site 34 | Rennes | |
| France | Site 52 | Rennes | |
| France | Site 75 | Rodez | |
| France | Site 35 | Roquebrune Cap Martin | |
| France | Site 36 | Rosny Sous Bois | |
| France | Site 202 | Saint Avertin | |
| France | Site 208 | Saint Avertin | |
| France | Site 313 | Saint-mandrier | |
| France | Site 113 | Segre | |
| France | Site 413 | Seysses | |
| France | Site 414 | Seysses | |
| France | Site 494 | Seysses | |
| France | Site 495 | Seysses | |
| France | Site 37 | Six Fours Les Plages | |
| France | Site 38 | Six Fours Les Plages | |
| France | Site 314 | Six-fours | |
| France | Site 457 | St Berthevin | |
| France | Site 489 | St Brice Courcelles | |
| France | Site 39 | Strasbourg | |
| France | Site 40 | Strasbourg | |
| France | Site 79 | Strasbourg | |
| France | Site 132 | Thouars | |
| France | Site 104 | Tierce | |
| France | Site 126 | Tierce | |
| France | Site 221 | Toulon | |
| France | Site 228 | Toulon | |
| France | Site 301 | Toulon | |
| France | Site 302 | Toulon | |
| France | Site 316 | Toulon | |
| France | Site 41 | Toulouse | |
| France | Site 42 | Toulouse | |
| France | Site 43 | Toulouse | |
| France | Site 44 | Toulouse | |
| France | Site 45 | Toulouse | |
| France | Site 503 | Toulouse | |
| France | Site 511 | Toulouse | |
| France | Site 201 | Tours | |
| France | Site 204 | Tours | |
| France | Site 401 | Tours | |
| France | Site 402 | Tours | |
| France | Site 405 | Tours | |
| France | Site 410 | Tours | |
| France | Site 112 | Trelaze | |
| France | Site 116 | Trelaze | |
| France | Site 72 | Vernet Les Bains | |
| France | Site 488 | Verzy | |
| France | Site 125 | Vihiers | |
| France | Site 127 | Villebernier |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
France,
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