ANZCTR - Registration

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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

Secondary ID [1]

Not aplicable

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mild to moderate osteoarthrits

Condition category

Condition code

Inflammatory and Immune System

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]

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]

Physical activity evaluation measured by WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire.

Timepoint [1]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/04/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

270

Accrual to date

Final

Recruitment outside Australia

Country [1]

Brazil

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Zodiac Produtos Farmaceuticos S.A.

Address [1]

Praca Prof. Jose Lannes, 40 - 15 andar
Sao Paulo

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CEP da Faculdade de Medicina do ABC

Ethics committee address [1]

Santo Andre

Ethics committee country [1]

Brazil

Date submitted for ethics approval [1]

10/12/2008

Approval date [1]

18/02/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Tatiana Ferian da Fonseca

Address

Rua Borges Lagoa, 1080 - cj101
São Paulo

Country

Brazil

Phone

55 11 5904 4454

Fax

tatiana@newcotrials.com

Contact person for scientific queries

Name

Tatiana Ferian da Fonseca

Address

Rua Borges Lagoa, 1080 - cj101
São Paulo

Country

Brazil

Phone

55 11 5904 4454

Fax

tatiana@newcotrials.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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