NCT00666523

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
Last Updated

April 25, 2008

Status Verified

April 1, 2008

Enrollment Period

1 year

First QC Date

April 23, 2008

Last Update Submit

April 23, 2008

Conditions

Osteoarthritis

Keywords

osteoarthritis, knee or hip

Outcome Measures

Primary Outcomes (1)

  • use of NSAIDs or analgesics

    3 months

Secondary Outcomes (1)

  • WOMAC function scale

    3 months

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: phytalgic

2

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

phytalgicDIETARY_SUPPLEMENT

3/day

1
placeboDIETARY_SUPPLEMENT

3/Day

2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • incapacity to understand study
  • irregular NSAID treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Pharmacology, U-Bordeaux2, BP36

Bordeaux, 33076, France

Location

Related Publications (1)

  • 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.

    PMID: 20015358DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Nicholas Moore, MD, PhD

    University of Bordeaux

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

April 1, 2008

Last Updated

April 25, 2008

Record last verified: 2008-04

Locations

FR(1)