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

Primary Purpose

Treatment, Osteoarthritis, Elderly

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
condroflex and exercise
sugar pill and exercise
Sponsored by
Zodiac Produtos Farmaceuticos S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment focused on measuring chondroitin, glucosamine, osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • previous drug treatment
  • concomitant diseases
  • concomitant drugs

Sites / Locations

  • CRDBRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

condroflex and exercise

sugar pill and exercise

Arm Description

assent arm

sugar pill arm

Outcomes

Primary Outcome Measures

improvement of pain

Secondary Outcome Measures

rigidity restriction

Full Information

First Posted
February 4, 2009
Last Updated
October 9, 2009
Sponsor
Zodiac Produtos Farmaceuticos S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00838487
Brief Title
Evaluate Safety & Efficacy of Condroflex in Subjects With OA
Acronym
ZD20108
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 Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zodiac Produtos Farmaceuticos S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment, Osteoarthritis, Elderly
Keywords
chondroitin, glucosamine, osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
condroflex and exercise
Arm Type
Active Comparator
Arm Description
assent arm
Arm Title
sugar pill and exercise
Arm Type
Placebo Comparator
Arm Description
sugar pill arm
Intervention Type
Other
Intervention Name(s)
condroflex and exercise
Other Intervention Name(s)
glucosamine sulph + chondroitin sulph and therapeutic exerc.
Intervention Description
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
Intervention Type
Other
Intervention Name(s)
sugar pill and exercise
Other Intervention Name(s)
Placebo Comparator and therapeutic exerc.
Intervention Description
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
Primary Outcome Measure Information:
Title
improvement of pain
Time Frame
12 week
Secondary Outcome Measure Information:
Title
rigidity restriction
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suely Roizenblatt
Phone
55 11 5908-7081
Email
suelyroi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Magda Bignotto
Phone
55 11 5908-7081
Email
magda@afip.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suely Roizenblatt
Organizational Affiliation
CRM Regional Council of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRDB
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suely Roizenblatt, Dra.
Phone
55 11 5908-7081
Email
suelyroi@gmail.com
First Name & Middle Initial & Last Name & Degree
Magda Bgnotto, Dra.
Phone
55 11 5908-7081
Email
magda@afip.com.br
First Name & Middle Initial & Last Name & Degree
Suely Roizenblatt

12. IPD Sharing Statement

Learn more about this trial

Evaluate Safety & Efficacy of Condroflex in Subjects With OA

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