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Trial registered on ANZCTR


Registration number
ACTRN12608000568314
Ethics application status
Approved
Date submitted
27/10/2008
Date registered
12/11/2008
Date last updated
19/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 3, duble-blind, randomized, parallel study to evaluate the efficacy of glucosamine sulfate and meloxicam administered in combination or glucosamine sulfate and meloxicam administered separately to subjects with mild to moderate osteoarthiritis of the knee or hip
Scientific title
Phase 3, duble-blind, randomized, parallel study to evaluate the efficacy of glucosamine sulfate and meloxicam administered in combination or glucosamine sulfate and meloxicam administered separately to subjects with mild to moderate osteoarthiritis of the knee or hip
Secondary ID [1] 252341 0
Not aplicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate osteoarthrits 3961 0
Condition category
Condition code
Inflammatory and Immune System 4157 4157 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination of Glucosamine sulfate 1.500mg and Meloxicam 15mg, administration daily orally, during 12 weeks (84 days). 1 powder packet, diluting in water, once a day.
Intervention code [1] 3680 0
Treatment: Drugs
Comparator / control treatment
Control group 1: Glucosamine sulfate 1.500mg + Meloxican placebo (pill - the same substances except for Meloxicam), administration daily orally during 12 weeks (84 days). 1 powder packet ( diluting in water) and 1 tablet, once a day. Control group 2: Meloxicam 15mg + Glucosamine sulfate placebo (Packet - the same subtances except for Glicosamine sulfate) , administration daily orally during 12 weeks (84 days). 1 tabelt and 1 powder packet (diluting in water) once a day.
Control group
Active

Outcomes
Primary outcome [1] 5054 0
Physical activity evaluation measured by WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire.
Timepoint [1] 5054 0
Evaluation will be measured in baseline - visit 2 (randomization day), visit 3 (week 2), visit 4 (week 4), visit 5 (week 6), visit 6 (week 8), visit 7 (week 10), visit 8 (week 12 - end of treatment period)
Secondary outcome [1] 8500 0
Safety measured by patient adverse event reports (serious and non serious adverse event). Glucosamine sulfate and meloxicam can presents skin alergy reaction, gastric problems and headaches but this symptoms are rare. However, every single adverse event presented during the study (15 weeks - screening, baseline, treatement period and follow-up period) will be followed. The adverse events will be assessed by patients reports during each visit and/or patient contact at any time. Non serious adverse events will be recorded at the Case Report Form (CRF) and serious adverse events will be recorded on a special adverse event report form (e.g. Council for international Organizations of Medical Sciences - CIOMS).

Safety will be also measured by laboratory exams performed in visits 1 (screening), 4(week 4), 6 (week 8) and 8 (week 12) to check if it is still normal.
Timepoint [1] 8500 0
Adverse event - during all study (15 weeks): screening - time =0, baseline - 1 week, treatment period - 12 weeks and follow up period - 2 weeks

Laboratory exams - visits 1 (screening), 4(week 4), 6 (week 8) and 8 (week 12)

Eligibility
Key inclusion criteria
- Patients between 40 and 60 years old
- Knee or hip osteoarthritis radiologic and clinical diagnosis
- lesion intensity should be mild to moderate (level 2 or 3 in Kellgren-Lawrence classification)
- normal laboratory exams
- informed consent
Minimum age
40 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- not used corticosteroids during the last 30 days
- not used non steroidal antinflamatory during the last 7 days
- immunomodulators previous use
- intrarticular medication during the last 6 months
- previous surgery in knee or hip and prosthesis use
- pregnant
- organic disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1306 0
Brazil
State/province [1] 1306 0

Funding & Sponsors
Funding source category [1] 4140 0
Commercial sector/Industry
Name [1] 4140 0
Zodiac Produtos Farmaceuticos S.A.
Address [1] 4140 0
Praca Prof. Jose Lannes, 40 - 15 andar
Sao Paulo
Country [1] 4140 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Zodiac Produtos Farmacêuticos S.A.
Address
Praça Prof. José Lannes, 40 - 15 andar
Sao Paulo
Country
Brazil
Secondary sponsor category [1] 3727 0
None
Name [1] 3727 0
Address [1] 3727 0
Country [1] 3727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6211 0
CEP da Faculdade de Medicina do ABC
Ethics committee address [1] 6211 0
Santo Andre
Ethics committee country [1] 6211 0
Brazil
Date submitted for ethics approval [1] 6211 0
10/12/2008
Approval date [1] 6211 0
18/02/2009
Ethics approval number [1] 6211 0

Summary
Brief summary
Arthritis is a generic term that refers to the inflammatory process that occurs in one or more joints. Among the causes of arthritis, the osteoarthritis (OA), also called osteoarthrosis, it’s the most frequent one (Myers e cols., 2007).
Previously considered to be a degenerative disease, OA is known today as a metabolically dynamic disease, with repairing mechanisms that involve the cartilage and the underlying bone tissue of the joints (Jones & Doherty, 1995).
OA is a result of mechanical or biological events that interfere with the delicate balance between production and degradation of the cartilage tissue and the bone immediately beneath it. It attacks all the joint tissues and it is characterized by morphological, biochemical, molecular and biomechanical changes.
Over the last few years, the possible treatments for OA have been largely studied all over the world. All these studies strive to provide a drug or a therapeutic combination that brings more comfort to the patient and improves his or her quality of life. In this sense, the ultimate goal is to alleviate symptoms of pain (acute or chronic), increase functional physical capacity and help repair the affected cartilage.
Pre-clinical studies had shown that orally absorbed glucosamine helps restitute the components lost during natural degradation of OA and increases production of proteoglicans by the chondrocytes when associated with Meloxicam.
Combination of an anti-inflammatory / analgesic drug and a cartilage regenerator like SYSADOA (SYmptomatic Slow-Acting Drugs in Osteoarthritis) is the objective for a more complete approach in the treatment of OA.
The proposed therapy with this new association aims to keep work capacity in young adults (40 to 60 years old) that have the chronic and potentially incapacitating form of the disease.
The purpose of this study is to compare, after 12 weeks of double-blind oral administration of this therapy, the physical activity rate achieved by the subjects assigned to the different therapeutic branches, which will be analyzed by the WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire filled out by individuals with knee or hip OA of mild to moderate intensity and not exposed to previous treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29071 0
Address 29071 0
Country 29071 0
Phone 29071 0
Fax 29071 0
Email 29071 0
Contact person for public queries
Name 12228 0
Tatiana Ferian da Fonseca
Address 12228 0
Rua Borges Lagoa, 1080 - cj101
São Paulo
Country 12228 0
Brazil
Phone 12228 0
55 11 5904 4454
Fax 12228 0
Email 12228 0
tatiana@newcotrials.com
Contact person for scientific queries
Name 3156 0
Tatiana Ferian da Fonseca
Address 3156 0
Rua Borges Lagoa, 1080 - cj101
São Paulo
Country 3156 0
Brazil
Phone 3156 0
55 11 5904 4454
Fax 3156 0
Email 3156 0
tatiana@newcotrials.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary