Effect of Artronat on the Quality of Life of Patient With... | NCT01356199

Studies
Effect of Artronat on the Quality of Life of Patient With Osteoarthritis

NCT01356199

Sponsor

Lescuyer Laboratory

Status

Completed

Last Update Posted

Mar 18, 2014Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

ARTRONAT
PLACEBO

Countries

France

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

May 17, 2011

First Submission Date that Met QC Criteria

May 18, 2011

First Posted Date

May 19, 2011Estimated

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

Mar 17, 2014

Last Update Posted Date

Mar 18, 2014Estimated

Name	Class
RDVC Produit de Santé.	UNKNOWN
Association Nationale de Prévention Médicale.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.

Detailed Description

Osteoarthritis is a degenerative disease that greatly impairs the quality of life of patients. A nutritional supplement may help, in association with the normal treatment of osteoarthritis, improving the quality of life of such patients, in reducing pain and/or improving join flexibility.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARTRONAT	Experimental		Dietary Supplement: ARTRONAT
PLACEBO	Placebo Comparator		Dietary Supplement: PLACEBO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARTRONAT	Dietary Supplement	Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.	ARTRONAT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of gonalgia	measure with the WOMAC.	T8 months

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the satisfactory relief of symptoms of osteoarthritis at each visit after the beginning of supplementation, assessed by the patients.	Subjective global assessment measured on a 10-cm graduated scale (Visual Analogue Scale)	T2, T4, T6, T8 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 40-75 years
BMI 18.5-30
osteoarthritis type II or III

Exclusion Criteria:

osteoarthritis type I or IV
allergy to one of the component of the supplement
blood pressure > 14/8
history of knee surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maurice Cloarec, MD	Association Nationale de Prevention Medicale	Study Chair
Dominique Baron, MD	Hospital Center of Lanion	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion		Treviou Treguignec		22660	France

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