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Trial Outcomes & Findings for Effect of Probenecid on Synovial Fluid ATP Levels in CPPD (NCT NCT02243631)

NCT ID: NCT02243631

Last Updated: 2022-07-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

8 participants

Primary outcome timeframe

5 days

Results posted on

2022-07-26

Participant Flow

Participant milestones

Participant milestones
Measure
Probenecid
These patients will receive 5 days of probenecid. Probenecid: Treatment
No Intervention
These patients will receive no intervention.
Overall Study
STARTED
3
5
Overall Study
COMPLETED
3
4
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Probenecid
These patients will receive 5 days of probenecid. Probenecid: Treatment
No Intervention
These patients will receive no intervention.
Overall Study
no synovial fluid on second aspirate
0
1

Baseline Characteristics

Effect of Probenecid on Synovial Fluid ATP Levels in CPPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Probenecid
n=3 Participants
These patients will receive 5 days of probenecid. Probenecid: Treatment
No Intervention
n=5 Participants
These patients will receive no intervention.
Total
n=8 Participants
Total of all reporting groups
Age, Continuous
77.6 years
STANDARD_DEVIATION 12.3 • n=99 Participants
68.4 years
STANDARD_DEVIATION 10.4 • n=107 Participants
71.8 years
STANDARD_DEVIATION 11.3 • n=206 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Male
3 Participants
n=99 Participants
5 Participants
n=107 Participants
8 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
White
3 Participants
n=99 Participants
5 Participants
n=107 Participants
8 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
3 Participants
n=99 Participants
5 Participants
n=107 Participants
8 Participants
n=206 Participants
ATP levels in synovial fluid at day 0
1.2 nanomoles/ml
STANDARD_DEVIATION 0.9 • n=99 Participants
4.5 nanomoles/ml
STANDARD_DEVIATION 6.7 • n=107 Participants
2.85 nanomoles/ml
STANDARD_DEVIATION 2.33 • n=206 Participants

PRIMARY outcome

Timeframe: 5 days

Population: Two subjects ( one in probenecid and one in no intervention group) had no measurable ATP on the second aspirate, and one subject in the no intervention group did not have any synovial fluid on the second visit.

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.

Outcome measures

Outcome measures
Measure
Probenecid
n=2 Participants
probenecid group after 5 days of drug
no Intervention
n=3 Participants
no intervention after 5 days
ATP Levels in Synovial Fluid
4.4 nanomoles/ml
Standard Deviation 2.5
31.4 nanomoles/ml
Standard Deviation 56.6

Adverse Events

Probenecid

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ann Rosenthal , MD ACOS/Research

Zablocki VA Medical Center

Phone: 414-384-2000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place