Trial Outcomes & Findings for A Proof-of-Concept Study of AC-201 to Prevent Gout Flares (NCT NCT01712204)
NCT ID: NCT01712204
Last Updated: 2018-05-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-05-22
Participant Flow
Overall, 82 patients from 8 clinical centers participated in the study between 28 January 2013 to 04 September 2013.
Participants were assessed at an initial screening visit within 2 weeks before the baseline visit.
Participant milestones
| Measure |
Placebo
Placebo Capsule BID for 16 Weeks
|
AC-201
AC-201 50mg Capsule BID for 16 Weeks
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
33
|
36
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Capsule BID for 16 Weeks
|
AC-201
AC-201 50mg Capsule BID for 16 Weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
Baseline characteristics by cohort
| Measure |
Placebo Capsule BID
n=41 Participants
Placebo Capsule BID for 16 Weeks
|
AC-201 50mg Capsule BID
n=41 Participants
AC-201 50mg Capsule BID for 16 Weeks
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
43.7 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
43.6 years
STANDARD_DEVIATION 12.1 • 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
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Placebo
n=41 Participants
Placebo Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)
|
AC-201
n=41 Participants
AC-201 50mg Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)
|
|---|---|---|
|
Number of Gout Flares Per Subject
|
3.02 flares
Interval 2.51 to 3.64
|
2.45 flares
Interval 2.01 to 3.0
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
AC-201
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Placebo Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)
|
AC-201
n=41 participants at risk
AC-201 50mg Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)
|
|---|---|---|
|
Metabolism and nutrition disorders
Frequent Gout Attack
|
2.4%
1/41 • Number of events 1 • 16 weeks
|
0.00%
0/41 • 16 weeks
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Placebo Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)
|
AC-201
n=41 participants at risk
AC-201 50mg Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)
|
|---|---|---|
|
Investigations
Blood CPK increased
|
9.8%
4/41 • Number of events 4 • 16 weeks
|
2.4%
1/41 • Number of events 1 • 16 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.3%
3/41 • Number of events 3 • 16 weeks
|
4.9%
2/41 • Number of events 2 • 16 weeks
|
|
Investigations
ALT increased
|
7.3%
3/41 • Number of events 3 • 16 weeks
|
0.00%
0/41 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.4%
1/41 • Number of events 1 • 16 weeks
|
4.9%
2/41 • Number of events 2 • 16 weeks
|
|
Renal and urinary disorders
Renal Impairment
|
2.4%
1/41 • Number of events 1 • 16 weeks
|
4.9%
2/41 • Number of events 2 • 16 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/41 • 16 weeks
|
4.9%
2/41 • Number of events 2 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/41 • 16 weeks
|
4.9%
2/41 • Number of events 2 • 16 weeks
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/41 • 16 weeks
|
4.9%
2/41 • Number of events 2 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60