CClinicalTrials.gg
Status unknownNCT00838487ZD20108Updated Oct 12, 2009

Evaluate Safety & Efficacy of Condroflex in Subjects With OA

A Phase 3 interventional study of condroflex and exercise and sugar pill and exercise in Treatment, Osteoarthritis and Elderly, sponsored by Zodiac Produtos Farmaceuticos S.A.. Status unknown at 1 site in Brazil. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-10-12.

Sponsored by Zodiac Produtos Farmaceuticos S.A. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Treatment
  • Osteoarthritis
  • Elderly

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Keywords

  • chondroitin
  • glucosamine
  • osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 240 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Zodiac Produtos Farmaceuticos S.A. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • previous drug treatment
  • concomitant diseases
  • concomitant drugs
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (estimated)

Study arms

  • Active comparator
    condroflex and exercise

    assent arm

    Other: condroflex and exercise

  • Placebo comparator
    sugar pill and exercise

    sugar pill arm

    Other: sugar pill and exercise

Interventions

  • Othercondroflex and exercise

    1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week

    Also known as: glucosamine sulph + chondroitin sulph and therapeutic exerc.

  • Othersugar pill and exercise

    1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week

    Also known as: Placebo Comparator and therapeutic exerc.

06

What researchers measure

Primary outcomes

  1. improvement of pain

    Time frame: 12 week

Secondary outcomes

  1. rigidity restriction

    Time frame: 12 week

07

Study locations

1 of 1 sites recruiting
  • CRDB
    São Paulo, Brazil
    • Suely Roizenblatt, Dra. · Contact · suelyroi@gmail.com · 55 11 5908-7081
    • Magda Bgnotto, Dra. · Contact · magda@afip.com.br · 55 11 5908-7081
    • Suely Roizenblatt · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00838487
Lead sponsor
Zodiac Produtos Farmaceuticos S.A.
First posted
Feb 6, 2009
Start date
Mar 2009
Primary completion
Jul 2009 (estimated)
Completion
Mar 2010 (estimated)
Last update
Oct 12, 2009

Study contacts

Suely Roizenblatt
Contact
suelyroi@gmail.com
55 11 5908-7081
Magda Bignotto
Contact
magda@afip.com.br
55 11 5908-7081
Suely Roizenblatt
principal investigator · CRM Regional Council of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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