NCT02243631

Brief Summary

This study will investigate the hypothesis that probenecid, a medication currently used for gout, reduces levels of ATP in the joint fluid of patients with calcium pyrophosphate deposition disease (CPPD), another common type of crystal-related arthritis. There is good evidence that CPPD results from an excess of ATP in joints. The investigators will measure levels of ATP in joint fluid before and after 5 days of treatment with probenecid. This study will serve to rationalize larger studies of probenecid in CPPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Oct 2014

Longer than P75 for early_phase_1

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

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

October 15, 2014

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 26, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

6.5 years

First QC Date

September 16, 2014

Results QC Date

March 24, 2022

Last Update Submit

July 22, 2022

Conditions

Keywords

ATPProbenecidChondrocalcinosis

Outcome Measures

Primary Outcomes (1)

  • ATP Levels in Synovial Fluid

    The investigators will measure levels of ATP in synovial fluid from patients with CPPD before and after treatment with probenecid compared to patients receiving no therapy. ATP levels are measured with a standard bioluminescent assay.

    5 days

Study Arms (2)

Probenecid

EXPERIMENTAL

These patients will receive 5 days of probenecid.

Drug: Probenecid

No intervention

NO INTERVENTION

These patients will receive no intervention.

Interventions

Treatment

Also known as: uricosuric
Probenecid

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>21 years,
  • CPPD diagnosed by Ryan /McCarty criteria
  • Joint effusion in a shoulder or knee

You may not qualify if:

  • Inability to sign informed consent
  • Age \<21 years
  • History of renal stones
  • Significant renal dysfunction (CKD \>stage 2)
  • Blood dyscrasias
  • Current use of drugs which interact with probenecid
  • Concurrent gout
  • Active infection, including bacteremia and overlying cellulitis
  • Recent joint trauma
  • Intra-articular corticosteroids in the affected joint within three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-1000, United States

Location

MeSH Terms

Conditions

Chondrocalcinosis

Interventions

ProbenecidUricosuric Agents

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsGout SuppressantsAntirheumatic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Dr. Ann Rosenthal , MD ACOS/Research
Organization
Zablocki VA Medical Center

Study Officials

  • Ann K Rosenthal, MD

    Clement J. Zablocki VA Medical Center, Milwaukee, WI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 18, 2014

Study Start

October 15, 2014

Primary Completion

April 8, 2021

Study Completion

April 8, 2021

Last Updated

July 26, 2022

Results First Posted

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations