Trial Outcomes & Findings for MPC-004 for the Treatment of an Acute Gout Flare (NCT NCT00506883)
NCT ID: NCT00506883
Last Updated: 2012-11-01
Results Overview
Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
185 participants
Primary outcome timeframe
24 hours after baseline
Results posted on
2012-11-01
Participant Flow
In 2007 between 4 April and 3 December 813 patients were screened at 74 US treatment centers. 72 centers randomized a total 575 patients. 185 patients at 54 centers had a qualifying gout flare and 184 are included in the ITT population. The remaining, 390 patients had no flare or had a flare that failed to qualify for study medication use
813 patients with confirmed diagnosis of gout based on American College of Rheumatology criteria were screened. 575 patients qualified and were randomized within 28 days of screening. 238 patients failed screening. The vast majority, 235 (98.7%) failed to meet inclusion/exclusion criteria.
Participant milestones
| Measure |
High Dose Colchicine(MPC-004)
Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
|
Low Dose Colchicine(MPC-004)
Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
|
Placebo
Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
74
|
59
|
|
Overall Study
COMPLETED
|
45
|
71
|
55
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
4
|
Reasons for withdrawal
| Measure |
High Dose Colchicine(MPC-004)
Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
|
Low Dose Colchicine(MPC-004)
Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
|
Placebo
Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
|
Overall Study
Other
|
5
|
1
|
1
|
Baseline Characteristics
MPC-004 for the Treatment of an Acute Gout Flare
Baseline characteristics by cohort
| Measure |
High Dose Colchicine(MPC-004)
n=52 Participants
Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
|
Low Dose Colchicine(MPC-004)
n=74 Participants
Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
|
Placebo
n=59 Participants
Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
160 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Age Continuous
|
51.9 years
STANDARD_DEVIATION 10.02 • n=93 Participants
|
51.4 years
STANDARD_DEVIATION 11.79 • n=4 Participants
|
51.2 years
STANDARD_DEVIATION 11.36 • n=27 Participants
|
51.5 years
STANDARD_DEVIATION 11.12 • n=483 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
176 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 24 hours after baselinePopulation: The Intent-to-Treat (ITT) population(N=184) was used. The ITT group is defined as all patients who were randomized,and had a qualifying gout flare based on contact with the Gout Flare Call Center, who were instructed to begin taking and took at least one dose of the study drug study drug. One patient had a flare, but
Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.
Outcome measures
| Measure |
High Dose Colchicine(MPC-004)
n=52 Participants
Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
|
Low Dose Colchicine(MPC-004)
n=74 Participants
Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
|
Placebo
n=58 Participants
Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
|
|---|---|---|---|
|
Responders
|
17 Participants
|
28 Participants
|
9 Participants
|
Adverse Events
High Dose Colchicine(MPC-004)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Low Dose Colchicine(MPC-004)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose Colchicine(MPC-004)
n=52 participants at risk
Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
|
Low Dose Colchicine(MPC-004)
n=74 participants at risk
Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
|
Placebo
n=59 participants at risk
Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/52
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
76.9%
40/52 • Number of events 41
|
23.0%
17/74 • Number of events 18
|
13.6%
8/59 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
17.3%
9/52 • Number of events 9
|
4.1%
3/74 • Number of events 3
|
5.1%
3/59 • Number of events 3
|
|
General disorders
Vomiting
|
17.3%
9/52 • Number of events 9
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Erosive Duodenitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Erosive Gastritis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Cardiac disorders
Gastroesophageal Reflux Disease
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Hiatus Hernia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Fatigue
|
3.8%
2/52 • Number of events 2
|
1.4%
1/74 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Pyrexia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
General disorders
Lethargy
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Investigations
Alanine Aminotrasnferase Increased
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/52
|
1.4%
1/74 • Number of events 1
|
0.00%
0/59
|
|
Investigations
Aspartate Aminotransferase increased
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Investigations
Glucose Urine
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Investigations
Liver Function Test Abnormal
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Investigations
Protein Urine
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Investigations
Blood Phosphorous Decreased
|
0.00%
0/52
|
1.4%
1/74 • Number of events 1
|
0.00%
0/59
|
|
Investigations
Urinary Casts
|
0.00%
0/52
|
1.4%
1/74 • Number of events 1
|
0.00%
0/59
|
|
Investigations
Blood Creatinine Phosphokinase increased
|
0.00%
0/52
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/52
|
1.4%
1/74 • Number of events 1
|
0.00%
0/59
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/52
|
4.1%
3/74 • Number of events 3
|
1.7%
1/59 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/52
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/52
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/52
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/52
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1
|
1.4%
1/74 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
Renal and urinary disorders
Chromaturia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
1/52 • Number of events 1
|
2.7%
2/74 • Number of events 2
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/52
|
1.4%
1/74 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Urinary tract Infection
|
0.00%
0/52
|
1.4%
1/74 • Number of events 1
|
0.00%
0/59
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/52
|
0.00%
0/74
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
Melena
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.9%
1/52 • Number of events 1
|
0.00%
0/74
|
0.00%
0/59
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60