Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506883
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2007-07-23
Brief Title:
MPC-004 for the Treatment of an Acute Gout Flare
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Multicenter Randomized Double Blind Placebo Controlled Parallel Group 1 Week Dose Comparison Study to Evaluate the Efficacy Safety and Tolerability of MPC-004 in Patients With an Acute Gout Flare
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AGREE
Brief Summary:
This study is a multicenter randomized double-blind placebo-controlled parallel group dose-comparison to determine the efficacy and safety of a standard-dose of colchicine 48 mg versus low-dose colchicine 18 mg or placebo for acute gout flares
Detailed Description:
This study is a multi-center randomized double-blind placebo-controlled parallel group trial to compare the efficacy and safety of standard-dose colchicine STDtotal dose 48 mg versus low-dose colchicine total dose 18 mg or placebo for the treatment of acute gout flares Eight hundred and thirteen patients with a confirmed diagnosis of gout were screened 238 of the screened patients failed screening 235987 failed because they did not meet inclusionexclusion criteria The 575 eligible patients were randomly assigned 111 to one of three treatment groups At the randomization visit the investigator dispensed a blister card containing eight identical looking capsules in a combination of active drug and placebo capsules in a double blind fashion for use during their next gout flare Patients were instructed to self-initiate treatment with the study medication within 12 hours of a gout flare onset Gout flares were determined by calling a Gout Flare Call Center established for this purpose At Investigator discretion rescue medication could also be provided but patients were encouraged not to use rescue medication within the first 24 hours after starting treatment with study drug Of the 575 study participants 185 had a qualifying gout flare and 390 did not Patients used a diary to record study drug administration pain score the presence or absence of gastrointestinal adverse events nausea vomiting diarrhea and abdominal pain and the timing of any rescue medication use prior to beginning treatment and 1 2 3 4 5 6 7 8 16 24 32 40 48 56 64 and 72 hours after the start of dosing
The pain score was based on a scale of 1 - 10 where 1 was no pain and 10 was the worst pain imaginable Efficacy was defined as a 50 reduction in pain score in the target joint at 24 hours in patients who did not use rescue medicine The primary efficacy analysis was to be based on an Intent-to-Treat ITT population defined as all patients who were randomized contacted the Call Center and were instructed to begin taking study drug An otherwise qualified patient was excluded from the ITT population only if the patient returned a study drug blister pack completely unused
Secondary outcome measures compared the efficacy of STD dose colchicine to a low dose regimen and placebo using the same criteria for efficacy as for the primary outcome measure
Additional secondary outcome measures were time to 50 and 90 reduction in pain in the target joint analyzed by treatment group using Kaplan-Meier methods and the change in mean pain intensity from 0 to 72 hours plotted by time point for each treatment group
All safety analyses were carried out using the safety population defined as all patients who received at least one dose of study medication regardless of authorization by the Call Center To determine the safety of colchicine when administered via two different dose regimens all patients who had a gout flare were seen by the investigator as soon as possible after onset and evaluated until the flare and any adverse events resolved All adverse effects whether recorded by the patient in the diary or obtained by systematic evaluation by the investigator were recorded and reported in tabular form Treatment-emergent adverse events TEAE were summarized by MedDRA System Organ Class and preferred terms and tabulated according treatment arm overall incidence severity and relationship to study medication Multiple events within a patient were counted once and at greatest severity and closest relationship to study medication
The pain score was based on a scale of 1 - 10 where 1 was no pain and 10 was the worst pain imaginable Efficacy was defined as a 50 reduction in pain score in the target joint at 24 hours in patients who did not use rescue medicine The primary efficacy analysis was to be based on an Intent-to-Treat ITT population defined as all patients who were randomized contacted the Call Center and were instructed to begin taking study drug An otherwise qualified patient was excluded from the ITT population only if the patient returned a study drug blister pack completely unused
Secondary outcome measures compared the efficacy of STD dose colchicine to a low dose regimen and placebo using the same criteria for efficacy as for the primary outcome measure
Additional secondary outcome measures were time to 50 and 90 reduction in pain in the target joint analyzed by treatment group using Kaplan-Meier methods and the change in mean pain intensity from 0 to 72 hours plotted by time point for each treatment group
All safety analyses were carried out using the safety population defined as all patients who received at least one dose of study medication regardless of authorization by the Call Center To determine the safety of colchicine when administered via two different dose regimens all patients who had a gout flare were seen by the investigator as soon as possible after onset and evaluated until the flare and any adverse events resolved All adverse effects whether recorded by the patient in the diary or obtained by systematic evaluation by the investigator were recorded and reported in tabular form Treatment-emergent adverse events TEAE were summarized by MedDRA System Organ Class and preferred terms and tabulated according treatment arm overall incidence severity and relationship to study medication Multiple events within a patient were counted once and at greatest severity and closest relationship to study medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None