NCT00264225

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

171 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
Last Updated

February 20, 2008

Status Verified

February 1, 2008

First QC Date

December 9, 2005

Last Update Submit

February 15, 2008

Conditions

Keywords

osteoarthritis, pain

Interventions

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient unable to interrupt his/her NSAIDs to participate in the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (171)

Site 2

Albi, France

Location

Site 3

Andernos-les-Bains, France

Location

Site 101

Angers, France

Location

Site 103

Angers, France

Location

Site 105

Angers, France

Location

Site 106

Angers, France

Location

Site 107

Angers, France

Location

Site 108

Angers, France

Location

Site 109

Angers, France

Location

Site 110

Angers, France

Location

Site 117

Angers, France

Location

Site 121

Angers, France

Location

Site 123

Angers, France

Location

Site 124

Angers, France

Location

Site 129

Angers, France

Location

Site 134

Angers, France

Location

Site 138

Angers, France

Location

Site 140

Angers, France

Location

Site 453

Angers, France

Location

Site 496

Angers, France

Location

Site 498

Angers, France

Location

Site 215

Anzin, France

Location

Site 451

Avrillé, France

Location

Site 131

Bagneux, France

Location

Site 315

Bandol, France

Location

Site 4

Bassens, France

Location

Site 115

Beaucouzé, France

Location

Site 502

Beaumont-sur-Lèze, France

Location

Site 449

Beaupréau, France

Location

Site 213

Bersée, France

Location

Site 119

Bécon-les-Granits, France

Location

Site 135

Bécon-les-Granits, France

Location

Site 136

Bécon-les-Granits, France

Location

Site 506

Bérat, France

Location

Site 50

Béziers, France

Location

Site 55

Béziers, France

Location

Site 5

Bobigny, France

Location

Site 6

Bordeaux, France

Location

Site 122

Briollay, France

Location

Site 7

Brive-la-Gaillarde, France

Location

Site 8

Carpentras, France

Location

Site 76

Châlons-en-Champagne, France

Location

Site 9

Châlons-en-Champagne, France

Location

Site 432

Château-Gontier, France

Location

Site 433

Château-Gontier, France

Location

Site 48

Châtenay-Malabry, France

Location

Site 114

Chemillé-Melay, France

Location

Site 462

Cherbourg, France

Location

Site 10

Clamart, France

Location

Site 11

Clermont-Ferrand, France

Location

Site 12

Clermont-Ferrand, France

Location

Site 13

Clermont-Ferrand, France

Location

Site 14

Colmar, France

Location

Site 78

Colmar, France

Location

Site 219

Croix, France

Location

Site 15

Dijon, France

Location

Site 16

Dinan, France

Location

Site 17

Dinard, France

Location

Site 47

Dinard, France

Location

Site 507

Eaunes, France

Location

Site 120

Écouflant, France

Location

Site 18

Évreux, France

Location

Site 19

Évreux, France

Location

Site 46

Évreux, France

Location

Site 102

Fenioux, France

Location

Site 20

Fontenay Malabry, France

Location

Site 24

L'Union, France

Location

Site 306

La Garde, France

Location

Site 207

La Riche, France

Location

Site 209

La Riche, France

Location

Site 423

La Rochelle, France

Location

Site 318

La Seyne-sur-Mer, France

Location

Site 319

La Seyne-sur-Mer, France

Location

Site 320

La Seyne-sur-Mer, France

Location

Site 321

La Seyne-sur-Mer, France

Location

Site 454

Laval, France

Location

Site 458

Laval, France

Location

Site 459

Laval, France

Location

Site 460

Laval, France

Location

Site 461

Laval, France

Location

Site 224

Le Pradet, France

Location

Site 225

Le Pradet, France

Location

Site 118

Les Ponts-de-Cé, France

Location

Site 137

Les Ponts-de-Cé, France

Location

Site 21

Levallois-Perret, France

Location

Site 22

Libourne, France

Location

Site 23

Limoges, France

Location

Site 49

Lyon, France

Location

Site 53

Lyon, France

Location

Site 58

Lyon, France

Location

Site 59

Lyon, France

Location

Site 64

Lyon, France

Location

Site 25

Marseille, France

Location

Site 26

Marseille, France

Location

Site 27

Marseille, France

Location

Site 28

Marseille, France

Location

Site 77

Marseille, France

Location

Site 29

Mérignac, France

Location

Site 70

Millau, France

Location

Site 56

Montpellier, France

Location

Site 60

Montpellier, France

Location

Site 62

Montpellier, France

Location

Site 65

Montpellier, France

Location

Site 68

Montpellier, France

Location

Site 139

Montreuil-Bellay, France

Location

Site 133

Montrevault, France

Location

Site 30

Montrouge, France

Location

Site 51

Nice, France

Location

Site 54

Nice, France

Location

Site 57

Nice, France

Location

Site 61

Nice, France

Location

Site 71

Nice, France

Location

Site 74

Nice, France

Location

Site 63

Nîmes, France

Location

Site 67

Nîmes, France

Location

Site 69

Nîmes, France

Location

Site 73

Nîmes, France

Location

Site 130

Noyant, France

Location

Site 128

Parçay-les-Pins, France

Location

Site 31

Paris, France

Location

Site 32

Paris, France

Location

Site 66

Perpignan, France

Location

Site 33

Pont-de-l'Arche, France

Location

Site 34

Rennes, France

Location

Site 52

Rennes, France

Location

Site 75

Rodez, France

Location

Site 35

Roquebrune-Cap-Martin, France

Location

Site 36

Rosny-sous-Bois, France

Location

Site 202

Saint-Avertin, France

Location

Site 208

Saint-Avertin, France

Location

Site 457

Saint-Berthevin, France

Location

Site 489

Saint-Brice-Courcelles, France

Location

Site 313

Saint-Mandrier-sur-Mer, France

Location

Site 113

Segré, France

Location

Site 413

Seysses, France

Location

Site 414

Seysses, France

Location

Site 494

Seysses, France

Location

Site 495

Seysses, France

Location

Site 314

Six-Fours-les-Plages, France

Location

Site 37

Six-Fours-les-Plages, France

Location

Site 38

Six-Fours-les-Plages, France

Location

Site 39

Strasbourg, France

Location

Site 40

Strasbourg, France

Location

Site 79

Strasbourg, France

Location

Site 132

Thouars, France

Location

Site 104

Tiercé, France

Location

Site 126

Tiercé, France

Location

Site 221

Toulon, France

Location

Site 228

Toulon, France

Location

Site 301

Toulon, France

Location

Site 302

Toulon, France

Location

Site 316

Toulon, France

Location

Site 41

Toulouse, France

Location

Site 42

Toulouse, France

Location

Site 43

Toulouse, France

Location

Site 44

Toulouse, France

Location

Site 45

Toulouse, France

Location

Site 503

Toulouse, France

Location

Site 511

Toulouse, France

Location

Site 201

Tours, France

Location

Site 204

Tours, France

Location

Site 401

Tours, France

Location

Site 402

Tours, France

Location

Site 405

Tours, France

Location

Site 410

Tours, France

Location

Site 112

Trélazé, France

Location

Site 116

Trélazé, France

Location

Site 72

Vernet-les-Bains, France

Location

Site 488

Verzy, France

Location

Site 125

Vihiers, France

Location

Site 127

Villebernier, France

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

December 1, 2005

Last Updated

February 20, 2008

Record last verified: 2008-02

Locations