Evaluate Safety & Efficacy of Condroflex in Subjects With OA | NCT00838487

Studies
Evaluate Safety & Efficacy of Condroflex in Subjects With OA

NCT00838487

Sponsor

Zodiac Produtos Farmaceuticos S.A.

Status

Unknown status

Last Update Posted

Oct 12, 2009Estimated

Enrollment

240Estimated

Phase

Phase 3

Conditions

Treatment
Osteoarthritis
Elderly

Interventions

condroflex and exercise
sugar pill and exercise

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jul 2009Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Feb 4, 2009

First Submission Date that Met QC Criteria

Feb 5, 2009

First Posted Date

Feb 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2009

Last Update Posted Date

Oct 12, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
condroflex and exercise	Active Comparator	assent arm	Other: condroflex and exercise
sugar pill and exercise	Placebo Comparator	sugar pill arm	Other: sugar pill and exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
condroflex and exercise	Other	1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week	condroflex and exercise

Measure	Description	Time Frame
improvement of pain		12 week

Measure	Description	Time Frame
rigidity restriction		12 week

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Suely Roizenblatt	Contact	55 11 5908-7081		suelyroi@gmail.com
Magda Bignotto	Contact	55 11 5908-7081		magda@afip.com.br

Overall Officials

Name	Affiliation	Role
Suely Roizenblatt	CRM Regional Council of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CRDB	Recruiting	São Paulo			Brazil

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D000073893	Sugars

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided