A Phase 4 interventional study of Colchicine (Colcrys®) and placebo in Intercritical Gout, sponsored by Regeneron Pharmaceuticals. Completed at 37 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-05-12.
Sponsored by Regeneron Pharmaceuticals · Phase 4, Interventional, and Treatment
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
232 studies on the registry are indexed under Gout; 45 are open to participants now.
This study's enrollment of 82 is below the median of 121 across 202 interventional studies indexed under Gout.
Browse Gout studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
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Inclusion criteria include, but are not limited to the following:
Exclusion Criteria:
Exclusion criteria include, but are not limited to the following:
daily placebo dosing for 16 weeks with background allopurinol therapy
Drug: placebo · Drug: allopurinol
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
Drug: Colchicine (Colcrys®) · Drug: allopurinol
daily 0.6 mg colchicine dosing for 16 weeks
daily placebo dosing for 16 weeks
background therapy
Number of Gout Flares Per Participant From Day 1 to Week 16
Time frame: Day 1 to Week 16
Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
Time frame: Day 1 to Week 16
Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16
Time frame: Day 1 to Week 16
Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16
Time frame: Day 1 to Week 16
Overall, 82 patients from 20 clinical sites participated in the study between 19-October-2011 to 27-August-2012.
| Milestone | Placebo | Colchicine (Colcrys®) 0.6mg |
|---|---|---|
| Started | 41 | 41 |
| Completed | 32 | 33 |
| Not completed | 9 | 8 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Adverse event | 0 | 3 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: Lost to follow-up | 4 | 3 |
| gout flares | Placebo | Colchicine (Colcrys®) 0.6mg |
|---|---|---|
| Number of Gout Flares Per Participant From Day 1 to Week 16 | 1.1 ± 1.90 | 0.3 ± 0.56 |
| Percentage of Participants | Placebo | Colchicine (Colcrys®) 0.6mg |
|---|---|---|
| Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 | 43.9 (28.47 to 60.25) | 24.4 (12.36 to 40.30) |
| Percentage of Participants | Placebo | Colchicine (Colcrys®) 0.6mg |
|---|---|---|
| Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 | 24.4 (12.36 to 40.30) | 4.9 (0.60 to 16.53) |
| days | Placebo | Colchicine (Colcrys®) 0.6mg |
|---|---|---|
| Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 | 6.6 ± 13.20 | 1.6 ± 3.75 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/41 (0%) | 20/41 (48.8%) |
| Colchicine (Colcrys®) 0.6mg | — | 1/41 (2.4%) | 20/41 (48.8%) |
| Event | Placebo | Colchicine (Colcrys®) 0.6mg |
|---|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/41 | 1/41 |
| Event | Placebo | Colchicine (Colcrys®) 0.6mg |
|---|---|---|
| HeadacheNervous system disorders | 7/41 | 7/41 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/41 | 5/41 |
| Back painMusculoskeletal and connective tissue disorders | 1/41 | 3/41 |
| HypoaesthesiaNervous system disorders | 0/41 | 3/41 |
| NasopharyngitisInfections and infestations | 3/41 | 1/41 |
| DiarrhoeaGastrointestinal disorders | 3/41 | 1/41 |
| InsomniaPsychiatric disorders | 3/41 | 0/41 |
The study population consisted of adults who met the criteria of the ARA for acute arthritis of primary gout or had monosodium urate monohydrate microcrystals identified in joint fluid, had tophi present in joints or a history of polyarticular gout attacks, a history of ≥2 gout flares in the past year, and were initiating therapy with allopurinol.
| Age, Categorical(Participants) | Placebo | Colchicine (Colcrys®) 0.6mg | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 39 | 35 | 74 |
| >=65 years | 2 | 6 | 8 |
| Sex: Female, Male(Participants) | Placebo | Colchicine (Colcrys®) 0.6mg | Total |
|---|---|---|---|
| Female | 1 | 6 | 7 |
| Male | 40 | 35 | 75 |
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals