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Evaluate Safety & Efficacy of Condroflex in Subjects With OA (ZD20108)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Zodiac Produtos Farmaceuticos S.A..
Recruitment status was:  Recruiting
Information provided by:
Zodiac Produtos Farmaceuticos S.A. Identifier:
First received: February 4, 2009
Last updated: October 9, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Treatment Osteoarthritis Elderly Other: condroflex and exercise Other: sugar pill and exercise Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Zodiac Produtos Farmaceuticos S.A.:

Primary Outcome Measures:
  • improvement of pain [ Time Frame: 12 week ]

Secondary Outcome Measures:
  • rigidity restriction [ Time Frame: 12 week ]

Estimated Enrollment: 240
Study Start Date: March 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: condroflex and exercise
assent arm
Other: condroflex and exercise
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
Other Name: glucosamine sulph + chondroitin sulph and therapeutic exerc.
Placebo Comparator: sugar pill and exercise
sugar pill arm
Other: sugar pill and exercise
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
Other Name: Placebo Comparator and therapeutic exerc.

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

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • to have knee osteoarthritis degree 2 or 3
  • to be capable to consent

Exclusion Criteria:

  • previous drug treatment
  • concomitant diseases
  • concomitant drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00838487

Contact: Suely Roizenblatt 55 11 5908-7081
Contact: Magda Bignotto 55 11 5908-7081

CRDB Recruiting
São Paulo, Brazil
Contact: Suely Roizenblatt, Dra.    55 11 5908-7081   
Contact: Magda Bgnotto, Dra.    55 11 5908-7081   
Principal Investigator: Suely Roizenblatt         
Sponsors and Collaborators
Zodiac Produtos Farmaceuticos S.A.
Principal Investigator: Suely Roizenblatt CRM Regional Council of Medicine
  More Information

Responsible Party: Julio Cesar Nophal de Carvalho, Zodiac Produtos Farmaceuticos Identifier: NCT00838487     History of Changes
Other Study ID Numbers: ZODIAC
Study First Received: February 4, 2009
Last Updated: October 9, 2009

Keywords provided by Zodiac Produtos Farmaceuticos S.A.:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on August 21, 2017