Evaluate Safety & Efficacy of Condroflex in Subjects With OA

Osteoarthritis Clinical Trial

— ZD20108  

Official title:

Phase 3 Study, to Evaluate Safety & Efficacy of the Association Condroflex + Therapeutic Exercises Compared to Placebo + Therapeutic Exercises, in Subjects With Knee OA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00838487
• Other study ID #: ZODIAC
• Status: Recruiting
• Phase: Phase 3
• First received: February 4, 2009
• Last updated: October 9, 2009
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: October 2009
• Source: Zodiac Produtos Farmaceuticos S.A.
• Contact: Suely Roizenblatt
• Phone: 55 11 5908-7081
• Email: suelyroi[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.

Description:

To have osteoarthritis degree 2 or 3 / To be capable to consent

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• to have knee osteoarthritis degree 2 or 3

• to be capable to consent

Exclusion Criteria:

• previous drug treatment

• concomitant diseases

• concomitant drugs

Study Design

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

Related Conditions & MeSH terms

• Elderly
• Osteoarthritis
• Treatment

Intervention

Other:
• condroflex and exercise
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
• sugar pill and exercise
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week

Locations

Country	Name	City	State
Brazil	CRDB	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Zodiac Produtos Farmaceuticos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of pain		12 week	Yes
Secondary	rigidity restriction		12 week	Yes