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Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lamaline® , 3 different doses, Dafalgan codeine
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring osteoarthritis, pain

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 2
  • Site 3
  • Site 101
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  • Site 109
  • Site 110
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  • Site 451
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  • Site 449
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  • Site 55
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  • Site 78
  • Site 219
  • Site 15
  • Site 16
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  • Site 47
  • Site 507
  • Site 120
  • Site 18
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  • Site 46
  • Site 102
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  • Site 306
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  • Site 118
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  • Site 30
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  • Site 73
  • Site 130
  • Site 128
  • Site 31
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  • Site 66
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  • Site 34
  • Site 52
  • Site 75
  • Site 35
  • Site 36
  • Site 202
  • Site 208
  • Site 313
  • Site 113
  • Site 413
  • Site 414
  • Site 494
  • Site 495
  • Site 37
  • Site 38
  • Site 314
  • Site 457
  • Site 489
  • Site 39
  • Site 40
  • Site 79
  • Site 132
  • Site 104
  • Site 126
  • Site 221
  • Site 228
  • Site 301
  • Site 302
  • Site 316
  • Site 41
  • Site 42
  • Site 43
  • Site 44
  • Site 45
  • Site 503
  • Site 511
  • Site 201
  • Site 204
  • Site 401
  • Site 402
  • Site 405
  • Site 410
  • Site 112
  • Site 116
  • Site 72
  • Site 488
  • Site 125
  • Site 127

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 9, 2005
Last Updated
February 15, 2008
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00264225
Brief Title
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

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
osteoarthritis, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamaline® , 3 different doses, Dafalgan codeine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 2
City
Albi
Country
France
Facility Name
Site 3
City
Andernos Les Bains
Country
France
Facility Name
Site 101
City
Angers
Country
France
Facility Name
Site 103
City
Angers
Country
France
Facility Name
Site 105
City
Angers
Country
France
Facility Name
Site 106
City
Angers
Country
France
Facility Name
Site 107
City
Angers
Country
France
Facility Name
Site 108
City
Angers
Country
France
Facility Name
Site 109
City
Angers
Country
France
Facility Name
Site 110
City
Angers
Country
France
Facility Name
Site 117
City
Angers
Country
France
Facility Name
Site 121
City
Angers
Country
France
Facility Name
Site 123
City
Angers
Country
France
Facility Name
Site 124
City
Angers
Country
France
Facility Name
Site 129
City
Angers
Country
France
Facility Name
Site 134
City
Angers
Country
France
Facility Name
Site 138
City
Angers
Country
France
Facility Name
Site 140
City
Angers
Country
France
Facility Name
Site 453
City
Angers
Country
France
Facility Name
Site 496
City
Angers
Country
France
Facility Name
Site 498
City
Angers
Country
France
Facility Name
Site 215
City
Anzin
Country
France
Facility Name
Site 451
City
Avrille
Country
France
Facility Name
Site 131
City
Bagneux
Country
France
Facility Name
Site 315
City
Bandol
Country
France
Facility Name
Site 4
City
Bassens
Country
France
Facility Name
Site 115
City
Beaucouze
Country
France
Facility Name
Site 502
City
Beaumont Sur Leze
Country
France
Facility Name
Site 449
City
Beaupreau
Country
France
Facility Name
Site 119
City
Becon Les Granits
Country
France
Facility Name
Site 135
City
Becon Les Granits
Country
France
Facility Name
Site 136
City
Becon Les Granits
Country
France
Facility Name
Site 506
City
Berat
Country
France
Facility Name
Site 213
City
Bersee
Country
France
Facility Name
Site 50
City
Beziers
Country
France
Facility Name
Site 55
City
Beziers
Country
France
Facility Name
Site 5
City
Bobigny
Country
France
Facility Name
Site 6
City
Bordeaux
Country
France
Facility Name
Site 122
City
Briollay
Country
France
Facility Name
Site 7
City
Brive La Gaillarde
Country
France
Facility Name
Site 8
City
Carpentras
Country
France
Facility Name
Site 76
City
Chalons En Champagne
Country
France
Facility Name
Site 9
City
Chalons En Champagne
Country
France
Facility Name
Site 432
City
Chateau-Gontier
Country
France
Facility Name
Site 433
City
Chateau-Gontier
Country
France
Facility Name
Site 48
City
Chatenay Malabry
Country
France
Facility Name
Site 114
City
Chemille
Country
France
Facility Name
Site 462
City
Cherbourg
Country
France
Facility Name
Site 10
City
Clamart
Country
France
Facility Name
Site 11
City
Clermont Ferrand
Country
France
Facility Name
Site 12
City
Clermont Ferrand
Country
France
Facility Name
Site 13
City
Clermont Ferrand
Country
France
Facility Name
Site 14
City
Colmar
Country
France
Facility Name
Site 78
City
Colmar
Country
France
Facility Name
Site 219
City
Croix
Country
France
Facility Name
Site 15
City
Dijon
Country
France
Facility Name
Site 16
City
Dinan
Country
France
Facility Name
Site 17
City
Dinard
Country
France
Facility Name
Site 47
City
Dinard
Country
France
Facility Name
Site 507
City
Eaunes
Country
France
Facility Name
Site 120
City
Ecouflant
Country
France
Facility Name
Site 18
City
Evreux
Country
France
Facility Name
Site 19
City
Evreux
Country
France
Facility Name
Site 46
City
Evreux
Country
France
Facility Name
Site 102
City
Fenioux
Country
France
Facility Name
Site 20
City
Fontenay Malabry
Country
France
Facility Name
Site 24
City
L'union
Country
France
Facility Name
Site 306
City
La Garde
Country
France
Facility Name
Site 207
City
La Riche
Country
France
Facility Name
Site 209
City
La Riche
Country
France
Facility Name
Site 423
City
La Rochelle
Country
France
Facility Name
Site 318
City
La Seyne Sur Mer
Country
France
Facility Name
Site 319
City
La Seyne Sur Mer
Country
France
Facility Name
Site 320
City
La Seyne Sur Mer
Country
France
Facility Name
Site 321
City
La Seyne Sur Mer
Country
France
Facility Name
Site 454
City
Laval
Country
France
Facility Name
Site 458
City
Laval
Country
France
Facility Name
Site 459
City
Laval
Country
France
Facility Name
Site 460
City
Laval
Country
France
Facility Name
Site 461
City
Laval
Country
France
Facility Name
Site 224
City
Le Pradet
Country
France
Facility Name
Site 225
City
Le Pradet
Country
France
Facility Name
Site 118
City
Les Ponts de Ce
Country
France
Facility Name
Site 137
City
Les Ponts de Ce
Country
France
Facility Name
Site 21
City
Levallois Perret
Country
France
Facility Name
Site 22
City
Libourne
Country
France
Facility Name
Site 23
City
Limoges
Country
France
Facility Name
Site 49
City
Lyon
Country
France
Facility Name
Site 53
City
Lyon
Country
France
Facility Name
Site 58
City
Lyon
Country
France
Facility Name
Site 59
City
Lyon
Country
France
Facility Name
Site 64
City
Lyon
Country
France
Facility Name
Site 25
City
Marseille
Country
France
Facility Name
Site 26
City
Marseille
Country
France
Facility Name
Site 27
City
Marseille
Country
France
Facility Name
Site 28
City
Marseille
Country
France
Facility Name
Site 77
City
Marseille
Country
France
Facility Name
Site 29
City
Merignac
Country
France
Facility Name
Site 70
City
Millau
Country
France
Facility Name
Site 56
City
Montpellier
Country
France
Facility Name
Site 60
City
Montpellier
Country
France
Facility Name
Site 62
City
Montpellier
Country
France
Facility Name
Site 65
City
Montpellier
Country
France
Facility Name
Site 68
City
Montpellier
Country
France
Facility Name
Site 139
City
Montreuil Bellay
Country
France
Facility Name
Site 133
City
Montrevault
Country
France
Facility Name
Site 30
City
Montrouge
Country
France
Facility Name
Site 51
City
Nice
Country
France
Facility Name
Site 54
City
Nice
Country
France
Facility Name
Site 57
City
Nice
Country
France
Facility Name
Site 61
City
Nice
Country
France
Facility Name
Site 71
City
Nice
Country
France
Facility Name
Site 74
City
Nice
Country
France
Facility Name
Site 63
City
Nimes
Country
France
Facility Name
Site 67
City
Nimes
Country
France
Facility Name
Site 69
City
Nimes
Country
France
Facility Name
Site 73
City
Nimes
Country
France
Facility Name
Site 130
City
Noyant
Country
France
Facility Name
Site 128
City
Parcay Les Pins
Country
France
Facility Name
Site 31
City
Paris
Country
France
Facility Name
Site 32
City
Paris
Country
France
Facility Name
Site 66
City
Perpignan
Country
France
Facility Name
Site 33
City
Pont de L'arche
Country
France
Facility Name
Site 34
City
Rennes
Country
France
Facility Name
Site 52
City
Rennes
Country
France
Facility Name
Site 75
City
Rodez
Country
France
Facility Name
Site 35
City
Roquebrune Cap Martin
Country
France
Facility Name
Site 36
City
Rosny Sous Bois
Country
France
Facility Name
Site 202
City
Saint Avertin
Country
France
Facility Name
Site 208
City
Saint Avertin
Country
France
Facility Name
Site 313
City
Saint-mandrier
Country
France
Facility Name
Site 113
City
Segre
Country
France
Facility Name
Site 413
City
Seysses
Country
France
Facility Name
Site 414
City
Seysses
Country
France
Facility Name
Site 494
City
Seysses
Country
France
Facility Name
Site 495
City
Seysses
Country
France
Facility Name
Site 37
City
Six Fours Les Plages
Country
France
Facility Name
Site 38
City
Six Fours Les Plages
Country
France
Facility Name
Site 314
City
Six-fours
Country
France
Facility Name
Site 457
City
St Berthevin
Country
France
Facility Name
Site 489
City
St Brice Courcelles
Country
France
Facility Name
Site 39
City
Strasbourg
Country
France
Facility Name
Site 40
City
Strasbourg
Country
France
Facility Name
Site 79
City
Strasbourg
Country
France
Facility Name
Site 132
City
Thouars
Country
France
Facility Name
Site 104
City
Tierce
Country
France
Facility Name
Site 126
City
Tierce
Country
France
Facility Name
Site 221
City
Toulon
Country
France
Facility Name
Site 228
City
Toulon
Country
France
Facility Name
Site 301
City
Toulon
Country
France
Facility Name
Site 302
City
Toulon
Country
France
Facility Name
Site 316
City
Toulon
Country
France
Facility Name
Site 41
City
Toulouse
Country
France
Facility Name
Site 42
City
Toulouse
Country
France
Facility Name
Site 43
City
Toulouse
Country
France
Facility Name
Site 44
City
Toulouse
Country
France
Facility Name
Site 45
City
Toulouse
Country
France
Facility Name
Site 503
City
Toulouse
Country
France
Facility Name
Site 511
City
Toulouse
Country
France
Facility Name
Site 201
City
Tours
Country
France
Facility Name
Site 204
City
Tours
Country
France
Facility Name
Site 401
City
Tours
Country
France
Facility Name
Site 402
City
Tours
Country
France
Facility Name
Site 405
City
Tours
Country
France
Facility Name
Site 410
City
Tours
Country
France
Facility Name
Site 112
City
Trelaze
Country
France
Facility Name
Site 116
City
Trelaze
Country
France
Facility Name
Site 72
City
Vernet Les Bains
Country
France
Facility Name
Site 488
City
Verzy
Country
France
Facility Name
Site 125
City
Vihiers
Country
France
Facility Name
Site 127
City
Villebernier
Country
France

12. IPD Sharing Statement

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Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)

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