Effect of Phytalgic in Osteoarthritis (OA) | NCT00666523

Studies
Effect of Phytalgic in Osteoarthritis (OA)

NCT00666523

Sponsor

Université Victor Segalen Bordeaux 2

Status

Completed

Last Update Posted

Apr 25, 2008Estimated

Enrollment

81Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

phytalgic
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

Apr 2008

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

Jan 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Apr 23, 2008

First Submission Date that Met QC Criteria

Apr 23, 2008

First Posted Date

Apr 25, 2008Estimated

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

Apr 23, 2008

Last Update Posted Date

Apr 25, 2008Estimated

Name	Class
laboratoire Phythea, France	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 objective of the study is to test the effects of a herbal supplement, Phytalgic, on the symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics on a regular basis.

Detailed Description

Not provided

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

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Dietary Supplement: phytalgic
2	Placebo Comparator		Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phytalgic	Dietary Supplement	3/day	1
placebo

Measure	Description	Time Frame
use of NSAIDs or analgesics		3 months

Measure	Description	Time Frame
WOMAC function scale		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

knee or hip osteoarthritis
regular NSAIDs/analgesic treatment
signed inform consent

Exclusion Criteria:

incapacity to understand study
irregular NSAID treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicholas Moore, MD, PhD	University of Bordeaux	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Pharmacology, U-Bordeaux2, BP36		Bordeaux		33076	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20015358	Derived	Jacquet A, Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial. Arthritis Res Ther. 2009;11(6):R192. doi: 10.1186/ar2891. Epub 2009 Dec 16.

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