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

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ClinicalTrials.gov Identifier: NCT00838487
Recruitment Status : Unknown
Verified October 2009 by Zodiac Produtos Farmaceuticos S.A..
Recruitment status was:  Recruiting
First Posted : February 6, 2009
Last Update Posted : October 12, 2009
Sponsor:
Information provided by:
Zodiac Produtos Farmaceuticos S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Treatment Osteoarthritis Elderly Other: condroflex and exercise Other: sugar pill and exercise Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Study Start Date : March 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



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

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


Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • previous drug treatment
  • concomitant diseases
  • concomitant drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838487


Contacts
Contact: Suely Roizenblatt 55 11 5908-7081 suelyroi@gmail.com
Contact: Magda Bignotto 55 11 5908-7081 magda@afip.com.br

Locations
Brazil
CRDB Recruiting
São Paulo, Brazil
Contact: Suely Roizenblatt, Dra.    55 11 5908-7081    suelyroi@gmail.com   
Contact: Magda Bgnotto, Dra.    55 11 5908-7081    magda@afip.com.br   
Principal Investigator: Suely Roizenblatt         
Sponsors and Collaborators
Zodiac Produtos Farmaceuticos S.A.
Investigators
Principal Investigator: Suely Roizenblatt CRM Regional Council of Medicine

Responsible Party: Julio Cesar Nophal de Carvalho, Zodiac Produtos Farmaceuticos
ClinicalTrials.gov Identifier: NCT00838487     History of Changes
Other Study ID Numbers: ZODIAC
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: October 12, 2009
Last Verified: October 2009

Keywords provided by Zodiac Produtos Farmaceuticos S.A.:
chondroitin
glucosamine
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases