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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

February 4, 2009
October 9, 2009
March 2009
July 2009   (final data collection date for primary outcome measure)
improvement of pain [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00838487 on ClinicalTrials.gov Archive Site
rigidity restriction [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluate Safety & Efficacy of Condroflex in Subjects With OA
Phase 3 Study, to Evaluate Safety & Efficacy of the Association Condroflex + Therapeutic Exercises Compared to Placebo + Therapeutic Exercises, in Subjects With Knee OA

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Treatment
  • Osteoarthritis
  • Elderly
  • 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.
  • 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.
  • Active Comparator: condroflex and exercise
    assent arm
    Intervention: Other: condroflex and exercise
  • Placebo Comparator: sugar pill and exercise
    sugar pill arm
    Intervention: Other: sugar pill and exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
March 2010
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • previous drug treatment
  • concomitant diseases
  • concomitant drugs
Both
40 Years to 70 Years
No
Contact: Suely Roizenblatt 55 11 5908-7081 suelyroi@gmail.com
Contact: Magda Bignotto 55 11 5908-7081 magda@afip.com.br
Brazil
 
NCT00838487
ZODIAC
Yes
Julio Cesar Nophal de Carvalho, Zodiac Produtos Farmaceuticos
Zodiac Produtos Farmaceuticos S.A.
Not Provided
Principal Investigator: Suely Roizenblatt CRM Regional Council of Medicine
Zodiac Produtos Farmaceuticos S.A.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP