Clinical trial NCT00264225: Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis, pain
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-12-12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albi
country: France
facility: Site 2
city: Andernos Les Bains
country: France
facility: Site 3
city: Angers
country: France
facility: Site 101
city: Angers
country: France
facility: Site 103
city: Angers
country: France
facility: Site 105
city: Angers
country: France
facility: Site 106
city: Angers
country: France
facility: Site 107
city: Angers
country: France
facility: Site 108
city: Angers
country: France
facility: Site 109
city: Angers
country: France
facility: Site 110
city: Angers
country: France
facility: Site 117
city: Angers
country: France
facility: Site 121
city: Angers
country: France
facility: Site 123
city: Angers
country: France
facility: Site 124
city: Angers
country: France
facility: Site 129
city: Angers
country: France
facility: Site 134
city: Angers
country: France
facility: Site 138
city: Angers
country: France
facility: Site 140
city: Angers
country: France
facility: Site 453
city: Angers
country: France
facility: Site 496
city: Angers
country: France
facility: Site 498
city: Anzin
country: France
facility: Site 215
city: Avrille
country: France
facility: Site 451
city: Bagneux
country: France
facility: Site 131
city: Bandol
country: France
facility: Site 315
city: Bassens
country: France
facility: Site 4
city: Beaucouze
country: France
facility: Site 115
city: Beaumont Sur Leze
country: France
facility: Site 502
city: Beaupreau
country: France
facility: Site 449
city: Becon Les Granits
country: France
facility: Site 119
city: Becon Les Granits
country: France
facility: Site 135
city: Becon Les Granits
country: France
facility: Site 136
city: Berat
country: France
facility: Site 506
city: Bersee
country: France
facility: Site 213
city: Beziers
country: France
facility: Site 50
city: Beziers
country: France
facility: Site 55
city: Bobigny
country: France
facility: Site 5
city: Bordeaux
country: France
facility: Site 6
city: Briollay
country: France
facility: Site 122
city: Brive La Gaillarde
country: France
facility: Site 7
city: Carpentras
country: France
facility: Site 8
city: Chalons En Champagne
country: France
facility: Site 76
city: Chalons En Champagne
country: France
facility: Site 9
city: Chateau-Gontier
country: France
facility: Site 432
city: Chateau-Gontier
country: France
facility: Site 433
city: Chatenay Malabry
country: France
facility: Site 48
city: Chemille
country: France
facility: Site 114
city: Cherbourg
country: France
facility: Site 462
city: Clamart
country: France
facility: Site 10
city: Clermont Ferrand
country: France
facility: Site 11
city: Clermont Ferrand
country: France
facility: Site 12
city: Clermont Ferrand
country: France
facility: Site 13
city: Colmar
country: France
facility: Site 14
city: Colmar
country: France
facility: Site 78
city: Croix
country: France
facility: Site 219
city: Dijon
country: France
facility: Site 15
city: Dinan
country: France
facility: Site 16
city: Dinard
country: France
facility: Site 17
city: Dinard
country: France
facility: Site 47
city: Eaunes
country: France
facility: Site 507
city: Ecouflant
country: France
facility: Site 120
city: Evreux
country: France
facility: Site 18
city: Evreux
country: France
facility: Site 19
city: Evreux
country: France
facility: Site 46
city: Fenioux
country: France
facility: Site 102
city: Fontenay Malabry
country: France
facility: Site 20
city: L'union
country: France
facility: Site 24
city: La Garde
country: France
facility: Site 306
city: La Riche
country: France
facility: Site 207
city: La Riche
country: France
facility: Site 209
city: La Rochelle
country: France
facility: Site 423
city: La Seyne Sur Mer
country: France
facility: Site 318
city: La Seyne Sur Mer
country: France
facility: Site 319
city: La Seyne Sur Mer
country: France
facility: Site 320
city: La Seyne Sur Mer
country: France
facility: Site 321
city: Laval
country: France
facility: Site 454
city: Laval
country: France
facility: Site 458
city: Laval
country: France
facility: Site 459
city: Laval
country: France
facility: Site 460
city: Laval
country: France
facility: Site 461
city: Le Pradet
country: France
facility: Site 224
city: Le Pradet
country: France
facility: Site 225
city: Les Ponts de Ce
country: France
facility: Site 118
city: Les Ponts de Ce
country: France
facility: Site 137
city: Levallois Perret
country: France
facility: Site 21
city: Libourne
country: France
facility: Site 22
city: Limoges
country: France
facility: Site 23
city: Lyon
country: France
facility: Site 49
city: Lyon
country: France
facility: Site 53
city: Lyon
country: France
facility: Site 58
city: Lyon
country: France
facility: Site 59
city: Lyon
country: France
facility: Site 64
city: Marseille
country: France
facility: Site 25
city: Marseille
country: France
facility: Site 26
city: Marseille
country: France
facility: Site 27
city: Marseille
country: France
facility: Site 28
city: Marseille
country: France
facility: Site 77
city: Merignac
country: France
facility: Site 29
city: Millau
country: France
facility: Site 70
city: Montpellier
country: France
facility: Site 56
city: Montpellier
country: France
facility: Site 60
city: Montpellier
country: France
facility: Site 62
city: Montpellier
country: France
facility: Site 65
city: Montpellier
country: France
facility: Site 68
city: Montreuil Bellay
country: France
facility: Site 139
city: Montrevault
country: France
facility: Site 133
city: Montrouge
country: France
facility: Site 30
city: Nice
country: France
facility: Site 51
city: Nice
country: France
facility: Site 54
city: Nice
country: France
facility: Site 57
city: Nice
country: France
facility: Site 61
city: Nice
country: France
facility: Site 71
city: Nice
country: France
facility: Site 74
city: Nimes
country: France
facility: Site 63
city: Nimes
country: France
facility: Site 67
city: Nimes
country: France
facility: Site 69
city: Nimes
country: France
facility: Site 73
city: Noyant
country: France
facility: Site 130
city: Parcay Les Pins
country: France
facility: Site 128
city: Paris
country: France
facility: Site 31
city: Paris
country: France
facility: Site 32
city: Perpignan
country: France
facility: Site 66
city: Pont de L'arche
country: France
facility: Site 33
city: Rennes
country: France
facility: Site 34
city: Rennes
country: France
facility: Site 52
city: Rodez
country: France
facility: Site 75
city: Roquebrune Cap Martin
country: France
facility: Site 35
city: Rosny Sous Bois
country: France
facility: Site 36
city: Saint Avertin
country: France
facility: Site 202
city: Saint Avertin
country: France
facility: Site 208
city: Saint-mandrier
country: France
facility: Site 313
city: Segre
country: France
facility: Site 113
city: Seysses
country: France
facility: Site 413
city: Seysses
country: France
facility: Site 414
city: Seysses
country: France
facility: Site 494
city: Seysses
country: France
facility: Site 495
city: Six Fours Les Plages
country: France
facility: Site 37
city: Six Fours Les Plages
country: France
facility: Site 38
city: Six-fours
country: France
facility: Site 314
city: St Berthevin
country: France
facility: Site 457
city: St Brice Courcelles
country: France
facility: Site 489
city: Strasbourg
country: France
facility: Site 39
city: Strasbourg
country: France
facility: Site 40
city: Strasbourg
country: France
facility: Site 79
city: Thouars
country: France
facility: Site 132
city: Tierce
country: France
facility: Site 104
city: Tierce
country: France
facility: Site 126
city: Toulon
country: France
facility: Site 221
city: Toulon
country: France
facility: Site 228
city: Toulon
country: France
facility: Site 301
city: Toulon
country: France
facility: Site 302
city: Toulon
country: France
facility: Site 316
city: Toulouse
country: France
facility: Site 41
city: Toulouse
country: France
facility: Site 42
city: Toulouse
country: France
facility: Site 43
city: Toulouse
country: France
facility: Site 44
city: Toulouse
country: France
facility: Site 45
city: Toulouse
country: France
facility: Site 503
city: Toulouse
country: France
facility: Site 511
city: Tours
country: France
facility: Site 201
city: Tours
country: France
facility: Site 204
city: Tours
country: France
facility: Site 401
city: Tours
country: France
facility: Site 402
city: Tours
country: France
facility: Site 405
city: Tours
country: France
facility: Site 410
city: Trelaze
country: France
facility: Site 112
city: Trelaze
country: France
facility: Site 116
city: Vernet Les Bains
country: France
facility: Site 72
city: Verzy
country: France
facility: Site 488
city: Vihiers
country: France
facility: Site 125
city: Villebernier
country: France
facility: Site 127
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: