Knee OsteoarthritisPhase 3NCT00264225
Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)
A Phase 3 study testing Lamaline® , 3 different doses, Dafalgan codeine in people with Knee Osteoarthritis, run by Solvay Pharmaceuticals at 171 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Lamaline® , 3 different doses, Dafalgan codeine
- How many people
- Not given
- Where
- 171 sitesFrance
- Study dates
- Dec 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient unable to interrupt his/her NSAIDs to participate in the clinical study
Trial locations and contacts
171 sites in 1 country.
171 sites in 1 country
France171 sites
Site 2
Albi
Site 3
Andernos-les-Bains
Site 101
Angers
Site 103
Angers
Site 105
Angers
Site 106
Angers
Site 107
Angers
Site 108
Angers
Site 109
Angers
Site 110
Angers
Site 117
Angers
Site 121
Angers
Site 123
Angers
Site 124
Angers
Site 129
Angers
Site 134
Angers
Site 138
Angers
Site 140
Angers
Site 453
Angers
Site 496
Angers
Site 498
Angers
Site 215
Anzin
Site 451
Avrillé
Site 131
Bagneux
Site 315
Bandol
Site 4
Bassens
Site 115
Beaucouzé
Site 502
Beaumont-sur-Lèze
Site 449
Beaupréau
Site 119
Bécon-les-Granits
Site 135
Bécon-les-Granits
Site 136
Bécon-les-Granits
Site 506
Bérat
Site 213
Bersée
Site 50
Béziers
Site 55
Béziers
Site 5
Bobigny
Site 6
Bordeaux
Site 122
Briollay
Site 7
Brive-la-Gaillarde
Site 8
Carpentras
Site 76
Châlons-en-Champagne
Site 9
Châlons-en-Champagne
Site 432
Château-Gontier
Site 433
Château-Gontier
Site 48
Châtenay-Malabry
Site 114
Chemillé-Melay
Site 462
Cherbourg
Site 10
Clamart
Site 11
Clermont-Ferrand
Site 12
Clermont-Ferrand
Site 13
Clermont-Ferrand
Site 14
Colmar
Site 78
Colmar
Site 219
Croix
Site 15
Dijon
Site 16
Dinan
Site 17
Dinard
Site 47
Dinard
Site 507
Eaunes
Site 120
Écouflant
Site 18
Évreux
Site 19
Évreux
Site 46
Évreux
Site 102
Fenioux
Site 20
Fontenay Malabry
Site 24
L'Union
Site 306
La Garde
Site 207
La Riche
Site 209
La Riche
Site 423
La Rochelle
Site 318
La Seyne-sur-Mer
Site 319
La Seyne-sur-Mer
Site 320
La Seyne-sur-Mer
Site 321
La Seyne-sur-Mer
Site 454
Laval
Site 458
Laval
Site 459
Laval
Site 460
Laval
Site 461
Laval
Site 224
Le Pradet
Site 225
Le Pradet
Site 118
Les Ponts-de-Cé
Site 137
Les Ponts-de-Cé
Site 21
Levallois-Perret
Site 22
Libourne
Site 23
Limoges
Site 49
Lyon
Site 53
Lyon
Site 58
Lyon
Site 59
Lyon
Site 64
Lyon
Site 25
Marseille
Site 26
Marseille
Site 27
Marseille
Site 28
Marseille
Site 77
Marseille
Site 29
Mérignac
Site 70
Millau
Site 56
Montpellier
Site 60
Montpellier
Site 62
Montpellier
Site 65
Montpellier
Site 68
Montpellier
Site 139
Montreuil-Bellay
Site 133
Montrevault
Site 30
Montrouge
Site 51
Nice
Site 54
Nice
Site 57
Nice
Site 61
Nice
Site 71
Nice
Site 74
Nice
Site 63
Nîmes
Site 67
Nîmes
Site 69
Nîmes
Site 73
Nîmes
Site 130
Noyant
Site 128
Parçay-les-Pins
Site 31
Paris
Site 32
Paris
Site 66
Perpignan
Site 33
Pont-de-l'Arche
Site 34
Rennes
Site 52
Rennes
Site 75
Rodez
Site 35
Roquebrune-Cap-Martin
Site 36
Rosny-sous-Bois
Site 202
Saint-Avertin
Site 208
Saint-Avertin
Site 457
Saint-Berthevin
Site 489
Saint-Brice-Courcelles
Site 313
Saint-Mandrier-sur-Mer
Site 113
Segré
Site 413
Seysses
Site 414
Seysses
Site 494
Seysses
Site 495
Seysses
Site 314
Six-Fours-les-Plages
Site 37
Six-Fours-les-Plages
Site 38
Six-Fours-les-Plages
Site 39
Strasbourg
Site 40
Strasbourg
Site 79
Strasbourg
Site 132
Thouars
Site 104
Tiercé
Site 126
Tiercé
Site 221
Toulon
Site 228
Toulon
Site 301
Toulon
Site 302
Toulon
Site 316
Toulon
Site 41
Toulouse
Site 42
Toulouse
Site 43
Toulouse
Site 44
Toulouse
Site 45
Toulouse
Site 503
Toulouse
Site 511
Toulouse
Site 201
Tours
Site 204
Tours
Site 401
Tours
Site 402
Tours
Site 405
Tours
Site 410
Tours
Site 112
Trélazé
Site 116
Trélazé
Site 72
Vernet-les-Bains
Site 488
Verzy
Site 125
Vihiers
Site 127
Villebernier
About this study
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
- Conditions
- Knee Osteoarthritis
- Being tested
- Lamaline® , 3 different doses, Dafalgan codeine
- Keywords
- osteoarthritis, pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamaline® , 3 different doses, Dafalgan codeineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264225
- Sponsor's protocol ID
- S118.3.005
- Other IDs
- 2005-003757-27, 2005
- Status last verified
- Feb 2008
- First submitted
- 9 Dec 2005
- Last updated
- 20 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00264225
- Acronym / sponsor ID
- S118.3.005
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient unable to interrupt his/her NSAIDs to participate in the clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamaline® , 3 different doses, Dafalgan codeine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2008.
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
171 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lamaline® , 3 different doses, Dafalgan codeine in people with Knee Osteoarthritis, run by Solvay Pharmaceuticals at 171 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 171 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2008.