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

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Knee Osteoarthritis

Intervention: LamalineĀ® , 3 different doses, Dafalgan codeine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Eligibility

Minimum age: 40 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- History of knee (unilateral or bilateral) osteoarthritis for at least 6 months

- Pain intensity assessed by Visual Analogue Scale ā‰„ 40 mm

- Partial functional disability assessed by Lequesne index ā‰„4 and < than 12

Exclusion Criteria:

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

Locations and Contacts

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

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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

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Site 454, Laval, France

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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

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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

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Site 301, Toulon, France

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Site 316, Toulon, France

Site 41, Toulouse, France

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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, France

Additional Information

Starting date: December 2005
Last updated: February 15, 2008

Page last updated: August 20, 2015

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