Trial Outcomes & Findings for A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout (NCT NCT02287818)
NCT ID: NCT02287818
Last Updated: 2022-06-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo plus Febuxostat
Placebo: Placebo twice daily from Day 1 to Week 12
Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
|
AC-201
AC-201 CR tablet plus Febuxostat
AC-201: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
67
|
|
Overall Study
COMPLETED
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Placebo plus Febuxostat
Placebo: Placebo twice daily from Day 1 to Week 12
Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
|
AC-201
n=67 Participants
AC-201 CR tablet plus Febuxostat
AC-201: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
47.3 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
47.4 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
121 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
|
60 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
127 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
Taiwan
|
60 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Placebo
n=60 Participants
Placebo plus Febuxostat
Placebo: Placebo twice daily from Day 1 to Week 12
Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
|
AC-201
n=67 Participants
AC-201 CR tablet plus Febuxostat
AC-201: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
|
|---|---|---|
|
Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL
|
33 Participants
|
43 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
AC-201
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Placebo plus Febuxostat
Placebo: Placebo twice daily from Day 1 to Week 12
Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
|
AC-201
n=67 participants at risk
AC-201 CR tablet plus Febuxostat
AC-201: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
1.7%
1/60
|
0.00%
0/67
|
|
Cardiac disorders
Cardiac disorders
|
1.7%
1/60
|
0.00%
0/67
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
11.7%
7/60
|
37.3%
25/67
|
|
General disorders
General disorders and administration site
|
1.7%
1/60
|
1.5%
1/67
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
1.7%
1/60
|
3.0%
2/67
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/60
|
1.5%
1/67
|
|
Infections and infestations
Infections and infestations
|
8.3%
5/60
|
9.0%
6/67
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
1.7%
1/60
|
0.00%
0/67
|
|
Investigations
Investigations
|
10.0%
6/60
|
9.0%
6/67
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/60
|
1.5%
1/67
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
10.0%
6/60
|
9.0%
6/67
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
1.7%
1/60
|
1.5%
1/67
|
|
Nervous system disorders
Nervous system disorders
|
1.7%
1/60
|
6.0%
4/67
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.7%
1/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
3.3%
2/60
|
0.00%
0/67
|
|
Skin and subcutaneous tissue disorders
Skin And subcutaneous tissue disorders
|
3.3%
2/60
|
1.5%
1/67
|
|
Vascular disorders
Vascular disorders
|
1.7%
1/60
|
0.00%
0/67
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place