Trial Outcomes & Findings for Open-Label Lesinurad Monotherapy Extension Study in Gout (NCT NCT01650246)
NCT ID: NCT01650246
Last Updated: 2016-05-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
143 participants
Primary outcome timeframe
Month 1
Results posted on
2016-05-26
Participant Flow
Participant milestones
| Measure |
Lesinurad 400 mg
lesinurad 400 mg once daily (qd)
|
|---|---|
|
Overall Study
STARTED
|
143
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
143
|
Reasons for withdrawal
| Measure |
Lesinurad 400 mg
lesinurad 400 mg once daily (qd)
|
|---|---|
|
Overall Study
Adverse Event
|
23
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Sponsor terminated study
|
53
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
26
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
30
|
Baseline Characteristics
Open-Label Lesinurad Monotherapy Extension Study in Gout
Baseline characteristics by cohort
| Measure |
Lesinurad 400 mg
n=143 Participants
lesinurad 400 mg once daily (qd)
|
|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
|
Age, Customized
<65 Years
|
111 Participants
n=93 Participants
|
|
Age, Customized
>=65 Years
|
32 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
9 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
6 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
6 Participants
n=93 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
South Africa
|
16 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
101 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: Safety Population
Outcome measures
| Measure |
Lesinurad 400 mg
n=143 Participants
lesinurad 400 mg once daily (qd)
|
|---|---|
|
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
|
68 Subjects
|
PRIMARY outcome
Timeframe: Up to approximately 2 yearsPopulation: Safety Population
Outcome measures
| Measure |
Lesinurad 400 mg
n=143 Participants
lesinurad 400 mg once daily (qd)
|
|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs)
|
105 TEAEs
|
Adverse Events
Lesinurad 400 mg
Serious events: 15 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lesinurad 400 mg
n=143 participants at risk
lesinurad 400 mg once daily (qd)
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.70%
1/143 • Number of events 1
|
|
General disorders
Death
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Bursitis infective
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.70%
1/143 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.70%
1/143 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.70%
1/143 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.70%
1/143 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.1%
3/143 • Number of events 3
|
|
Renal and urinary disorders
Renal impairment
|
0.70%
1/143 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.70%
1/143 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.70%
1/143 • Number of events 1
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.70%
1/143 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
0.70%
1/143 • Number of events 1
|
|
Cardiac disorders
Atrioventricular clock complete
|
0.70%
1/143 • Number of events 1
|
|
Cardiac disorders
Coronary Artery disease
|
0.70%
1/143 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.70%
1/143 • Number of events 1
|
Other adverse events
| Measure |
Lesinurad 400 mg
n=143 participants at risk
lesinurad 400 mg once daily (qd)
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
3/143 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
3/143 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
4/143 • Number of events 7
|
|
General disorders
Fatigue
|
2.8%
4/143 • Number of events 4
|
|
General disorders
Pyrexia
|
2.1%
3/143 • Number of events 3
|
|
Infections and infestations
Bronchitis
|
3.5%
5/143 • Number of events 5
|
|
Infections and infestations
Gastroenteritis
|
4.9%
7/143 • Number of events 8
|
|
Infections and infestations
Influenza
|
2.1%
3/143 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
2.8%
4/143 • Number of events 5
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
14/143 • Number of events 15
|
|
Infections and infestations
Urinary tract infection
|
4.9%
7/143 • Number of events 8
|
|
Investigations
Blood creatine phosphokinase increased
|
2.8%
4/143 • Number of events 4
|
|
Investigations
Blood creatinine increased
|
11.2%
16/143 • Number of events 20
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.1%
3/143 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
6/143 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
7/143 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.1%
3/143 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
3/143 • Number of events 4
|
|
Nervous system disorders
Headache
|
4.2%
6/143 • Number of events 8
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.1%
3/143 • Number of events 3
|
|
Renal and urinary disorders
Renal impairment
|
2.8%
4/143 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
4/143 • Number of events 5
|
|
Vascular disorders
Hypertension
|
7.0%
10/143 • Number of events 10
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
4/143 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator (PI) shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER