Evaluate Safety & Efficacy of Condroflex in Subjects With OA
ZD20108
Phase 3 Study, to Evaluate Safety & Efficacy of the Association Condroflex + Therapeutic Exercises Compared to Placebo + Therapeutic Exercises, in Subjects With Knee OA
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedOctober 12, 2009
October 1, 2009
4 months
February 4, 2009
October 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
improvement of pain
12 week
Secondary Outcomes (1)
rigidity restriction
12 week
Study Arms (2)
condroflex and exercise
ACTIVE COMPARATORassent arm
sugar pill and exercise
PLACEBO COMPARATORsugar pill arm
Interventions
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
Eligibility Criteria
You may qualify if:
- to have knee osteoarthritis degree 2 or 3
- to be capable to consent
You may not qualify if:
- previous drug treatment
- concomitant diseases
- concomitant drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CRDB
São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suely Roizenblatt
CRM Regional Council of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 6, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2009
Study Completion
March 1, 2010
Last Updated
October 12, 2009
Record last verified: 2009-10