Study of Association of Anti-inflammatory and Anti-rheumatic

Osteoarthritis Clinical Trial

— ZDPC00213  

Official title:

Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02448199
• Other study ID #: Zodiac Produtos Farmacêuticos
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 11, 2015
• Last updated: May 18, 2015
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: May 2015
• Source: Zodiac Produtos Farmaceuticos S.A.
• Contact: Carine F Sanches, Pharmacist
• Phone: 55 11 55015332
• Email: carine.sanches[@]zodiac.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.

Description:

Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 375
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Signs the Informed Consent Form

• Age between 40 and 85 years

• osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology

Exclusion Criteria:

• Cardiovascular disease

• Serious chronic comorbidity

• Hypersensitivity to any component of the study drugs

• body mass index> 30 kg / m²

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Meloxicam and Glucosamine
Experimental
• Meloxicam
Active Comparator
• Glucosamine
Active Comparator

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zodiac Produtos Farmaceuticos S.A.	Eurotrials Brasil Consultores Cientificos Ltda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment	Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment	12 weeks	No
Secondary	Safety measured by frequency of adverse event	Safety as measured by total frequency of adverse event during the 12 weeks of treatment	12 weeks	Yes