NCT00440661

Brief Summary

Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation mediators.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 4, 2010

Status Verified

October 1, 2007

Enrollment Period

1.6 years

First QC Date

February 26, 2007

Last Update Submit

March 3, 2010

Conditions

Osteoarthritis

Keywords

Osteoarthritis, IL-1

Outcome Measures

Primary Outcomes (1)

  • Synovial concentration of IL-1

Secondary Outcomes (2)

  • Synovial concentration of IL-6

  • WOMAC

Interventions

DiacerheinDRUG

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Painful osteoarthritis
  • Hydarthrosis (synovial effusion)

You may not qualify if:

  • large effusion
  • severe pathologies
  • anti-osteoarthritic treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatologic Institut of Montreal

Montreal, Quebec, H2L1S6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

diacerein

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jean-Pierre RAYNAULD, MD

    Institut de Rhumatologie de Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 4, 2010

Record last verified: 2007-10

Locations

CA(1)