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NCT00506883 · ClinicalTrials.gov registry record · Phase 3

MPC-004 for the Treatment of an Acute Gout Flare

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
185
Enrollment target

NCT00506883: Completed Phase 3 study, sponsored by Takeda.

NCT00506883 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 185 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00506883, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
185 participants
Enrollment target

Study 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 (4.8 mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares.

Primary Outcome

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.

Interventions

  • OTHER Placebo Control
  • DRUG High Dose Colchicine (4.8 mg total dose)
  • DRUG Low Dose Colchicine (1.8mg total dose)

Trial Details

FieldValue
Enrollment Target 185 participants
Start Date 2007-04
Est. Completion 2007-10
Phase Phase 3
Takeda

408 total trials

What the finished NCT00506883 record still lists

NCT00506883 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo Control is the first listed.

NCT00506883 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00506883 about?

NCT00506883 is a clinical study titled "MPC-004 for the Treatment of an Acute Gout Flare". 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 (4.8 mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares.

What is the current status of trial NCT00506883?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2007-04. Estimated completion is 2007-10.

What interventions are being tested in trial NCT00506883?

The interventions under investigation include: Placebo Control (OTHER), High Dose Colchicine (4.8 mg total dose) (DRUG), Low Dose Colchicine (1.8mg total dose) (DRUG).

Who is sponsoring clinical trial NCT00506883?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00506883's enrollment target sits among peer trials

185 1417th of 2000 higher than 583 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00506883, the US trial registry maintained by the National Library of Medicine. NCT00506883 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.