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MPC-004 for the Treatment of an Acute Gout Flare (AGREE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00506883
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : September 22, 2009
Last Update Posted : November 1, 2012
Sponsor:
Information provided by:
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: High Dose Colchicine (4.8 mg total dose)
Drug: Low Dose Colchicine (1.8mg total dose)
Other: Placebo Control
Enrollment 185
Recruitment Details 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
Pre-assignment Details 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.
Arm/Group Title High Dose Colchicine(MPC-004) Low Dose Colchicine(MPC-004) Placebo
Hide Arm/Group Description 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 - 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. Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
Period Title: Overall Study
Started 52 74 59
Completed 45 71 55
Not Completed 7 3 4
Reason Not Completed
Lost to Follow-up             1             1             1
Withdrawal by Subject             1             0             1
Lack of Efficacy             0             1             1
Other             5             1             1
Arm/Group Title High Dose Colchicine(MPC-004) Low Dose Colchicine(MPC-004) Placebo Total
Hide Arm/Group Description 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 - 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. 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 of all reporting groups
Overall Number of Baseline Participants 52 74 59 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 74 participants 59 participants 185 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  88.5%
61
  82.4%
53
  89.8%
160
  86.5%
>=65 years
6
  11.5%
13
  17.6%
6
  10.2%
25
  13.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 74 participants 59 participants 185 participants
51.9  (10.02) 51.4  (11.79) 51.2  (11.36) 51.5  (11.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 74 participants 59 participants 185 participants
Female
3
   5.8%
2
   2.7%
4
   6.8%
9
   4.9%
Male
49
  94.2%
72
  97.3%
55
  93.2%
176
  95.1%
1.Primary Outcome
Title Responders
Hide Description 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.
Time Frame 24 hours after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title High Dose Colchicine(MPC-004) Low Dose Colchicine(MPC-004) Placebo
Hide Arm/Group Description:
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 - 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.
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 Number of Participants Analyzed 52 74 58
Measure Type: Number
Unit of Measure: Participants
17 28 9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Colchicine(MPC-004) Low Dose Colchicine(MPC-004) Placebo
Hide Arm/Group Description 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 - 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. Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
All-Cause Mortality
High Dose Colchicine(MPC-004) Low Dose Colchicine(MPC-004) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
High Dose Colchicine(MPC-004) Low Dose Colchicine(MPC-004) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      0/74 (0.00%)      0/59 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.4%
High Dose Colchicine(MPC-004) Low Dose Colchicine(MPC-004) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/52 (76.92%)      27/74 (36.49%)      16/59 (27.12%)    
Cardiac disorders       
Gastroesophageal Reflux Disease  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/52 (0.00%)  0 0/74 (0.00%)  0 1/59 (1.69%)  1
Gastrointestinal disorders       
Diarrhea  1  40/52 (76.92%)  41 17/74 (22.97%)  18 8/59 (13.56%)  8
Nausea  1  9/52 (17.31%)  9 3/74 (4.05%)  3 3/59 (5.08%)  3
Abdominal Pain Lower  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Abdominal Pain Upper  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Dyspepsia  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Erosive Duodenitis  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Erosive Gastritis  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Hemorrhoids  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Hiatus Hernia  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Irritable Bowel Syndrome  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Abdominal Pain  1  1/52 (1.92%)  1 0/74 (0.00%)  0 1/59 (1.69%)  1
Constipation  1  0/52 (0.00%)  0 1/74 (1.35%)  1 0/59 (0.00%)  0
Abdominal Discomfort  1  0/52 (0.00%)  0 0/74 (0.00%)  0 2/59 (3.39%)  2
Melena  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
General disorders       
Vomiting  1  9/52 (17.31%)  9 0/74 (0.00%)  0 0/59 (0.00%)  0
Fatigue  1  2/52 (3.85%)  2 1/74 (1.35%)  1 1/59 (1.69%)  1
Pyrexia  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Lethargy  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Infections and infestations       
Urinary tract Infection  1  0/52 (0.00%)  0 1/74 (1.35%)  1 0/59 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  0/52 (0.00%)  0 1/74 (1.35%)  1 0/59 (0.00%)  0
Investigations       
Alanine Aminotrasnferase Increased  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Aspartate Aminotransferase increased  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Glucose Urine  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Liver Function Test Abnormal  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Protein Urine  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Blood Phosphorous Decreased  1  0/52 (0.00%)  0 1/74 (1.35%)  1 0/59 (0.00%)  0
Urinary Casts  1  0/52 (0.00%)  0 1/74 (1.35%)  1 0/59 (0.00%)  0
Blood Creatinine Phosphokinase increased  1  0/52 (0.00%)  0 0/74 (0.00%)  0 1/59 (1.69%)  1
Metabolism and nutrition disorders       
Gout  1  0/52 (0.00%)  0 3/74 (4.05%)  3 1/59 (1.69%)  1
Hypercholesterolemia  1  0/52 (0.00%)  0 0/74 (0.00%)  0 1/59 (1.69%)  1
Hypoglycemia  1  0/52 (0.00%)  0 0/74 (0.00%)  0 1/59 (1.69%)  1
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/52 (0.00%)  0 0/74 (0.00%)  0 1/59 (1.69%)  1
Arthropathy  1  0/52 (0.00%)  0 0/74 (0.00%)  0 1/59 (1.69%)  1
Pain in Extremity  2  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Nervous system disorders       
Headache  1  1/52 (1.92%)  1 1/74 (1.35%)  1 2/59 (3.39%)  2
Dizziness  1  0/52 (0.00%)  0 0/74 (0.00%)  0 1/59 (1.69%)  1
Renal and urinary disorders       
Chromaturia  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pharyngolaryngeal pain  1  1/52 (1.92%)  1 2/74 (2.70%)  2 0/59 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritis  1  1/52 (1.92%)  1 0/74 (0.00%)  0 0/59 (0.00%)  0
Rash  1  0/52 (0.00%)  0 1/74 (1.35%)  1 1/59 (1.69%)  1
Vascular disorders       
Hypertension  1  1/52 (1.92%)  1 0/74 (0.00%)  0 1/59 (1.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA 10.9
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: AR Scientific, Inc.
Phone: 215-697-1743
EMail: clinicaltrials@urlmutual.com
Layout table for additonal information
Responsible Party: Matthew Davis, MD, AR Scientific
ClinicalTrials.gov Identifier: NCT00506883    
Other Study ID Numbers: MPC 004-06-3001
First Submitted: July 23, 2007
First Posted: July 25, 2007
Results First Submitted: August 12, 2009
Results First Posted: September 22, 2009
Last Update Posted: November 1, 2012