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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Zodiac Produtos Farmaceuticos S.A..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zodiac Produtos Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT00838487
First received: February 4, 2009
Last updated: October 9, 2009
Last verified: October 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • improvement of pain [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • rigidity restriction [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Julio Cesar Nophal de Carvalho, Zodiac Produtos Farmaceuticos
ClinicalTrials.gov Identifier: NCT00838487     History of Changes
Other Study ID Numbers: ZODIAC
Study First Received: February 4, 2009
Last Updated: October 9, 2009
Health Authority: Brazil: National Health Surveillance Agency

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

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

ClinicalTrials.gov processed this record on May 19, 2013