Trial Outcomes & Findings for Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol (NCT NCT01451645)
NCT ID: NCT01451645
Last Updated: 2014-05-12
Results Overview
COMPLETED
PHASE4
82 participants
Day 1 to Week 16
2014-05-12
Participant Flow
Overall, 82 patients from 20 clinical sites participated in the study between 19-October-2011 to 27-August-2012.
Participants were assessed at an initial screening visit within 3 to 14 days before the baseline visit. At the baseline visit, eligible participants were then assessed, randomized, trained on daily dosing \& the daily dosing/flare diary, and initiated on allopurinol and study drug (colchicine or placebo).
Participant milestones
| Measure |
Placebo
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Placebo
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
n=41 Participants
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 16Population: Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).
Outcome measures
| Measure |
Placebo
n=41 Participants
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
n=41 Participants
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
|---|---|---|
|
Number of Gout Flares Per Participant From Day 1 to Week 16
|
1.1 gout flares
Standard Deviation 1.90
|
0.3 gout flares
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Day 1 to Week 16Population: Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).
Outcome measures
| Measure |
Placebo
n=41 Participants
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
n=41 Participants
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
|---|---|---|
|
Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
|
43.9 Percentage of Participants
Interval 28.47 to 60.25
|
24.4 Percentage of Participants
Interval 12.36 to 40.3
|
SECONDARY outcome
Timeframe: Day 1 to Week 16Population: Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).
Outcome measures
| Measure |
Placebo
n=41 Participants
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
n=41 Participants
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
|---|---|---|
|
Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16
|
24.4 Percentage of Participants
Interval 12.36 to 40.3
|
4.9 Percentage of Participants
Interval 0.6 to 16.53
|
SECONDARY outcome
Timeframe: Day 1 to Week 16Population: Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).
Outcome measures
| Measure |
Placebo
n=41 Participants
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
n=41 Participants
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
|---|---|---|
|
Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16
|
6.6 days
Standard Deviation 13.20
|
1.6 days
Standard Deviation 3.75
|
Adverse Events
Placebo
Colchicine (Colcrys®) 0.6mg
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
n=41 participants at risk
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/41
|
2.4%
1/41
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
daily placebo dosing for 16 weeks with background allopurinol therapy
|
Colchicine (Colcrys®) 0.6mg
n=41 participants at risk
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41
|
12.2%
5/41
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41
|
7.3%
3/41
|
|
Nervous system disorders
Headache
|
17.1%
7/41
|
17.1%
7/41
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/41
|
7.3%
3/41
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
3/41
|
2.4%
1/41
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
3/41
|
2.4%
1/41
|
|
Psychiatric disorders
Insomnia
|
7.3%
3/41
|
0.00%
0/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.
- Publication restrictions are in place
Restriction type: OTHER