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COMPLETED Phase 2

Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout

NCT00985127 · View on ClinicalTrials.gov ↗

Study Summary

The study will be conducted in two parts. The first is a parallel-group design, evaluating doses of 40 mg, 80 mg or 120 mg BCX-4208. The second part is planned as a dose-escalation study, evaluating higher doses including 160 mg, 240 mg and 320 mg BCX-4208. The study's primary endpoint is the change in uric acid in the blood compared to baseline measurement prior to treatment, assessed on Day 22.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG BCX4208

Study Locations (20)

Arizona

  • Radiant Research, Inc. — Scottsdale
  • Catalina Pointe Clinical Research — Tucson

California

  • Irvine Center for Clinical Research — Irvine
  • San Diego Arthritis Medical Clinic — San Diego

Florida

  • Avail Clinical Research — DeLand
  • Anchor Research Center — Naples

Hawaii

  • East-West Medical Research Institute — Honolulu

Idaho

  • Selah Medical Center — Boise

Kentucky

  • Kentucky Medical Research Center — Lexington

Maryland

  • Arthritis & Osteoporosis Center of Maryland — Frederick

Mississippi

  • Olive Branch Family Medical Center — Olive Branch

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2009-09
Est. Completion 2010-09
Phase Phase 2

Sponsor

BioCryst Pharmaceuticals

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00985127

The ClinicalTrials.gov registry entry for NCT00985127 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioCryst Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00985127 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00985127 about?

NCT00985127 is a clinical study titled "Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout". The study will be conducted in two parts. The first is a parallel-group design, evaluating doses of 40 mg, 80 mg or 120 mg BCX-4208. The second part is planned as a dose-escalation study, evaluating higher doses including 160 mg, 240 mg and 320 mg BCX-4208. The study's primary endpoint is the change...

What is the current status of trial NCT00985127?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2009-09. Estimated completion is 2010-09.

What conditions does trial NCT00985127 study?

This clinical trial studies the following conditions: Gout. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00985127?

The interventions under investigation include: placebo (DRUG), BCX4208 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00985127?

This trial is sponsored by BioCryst Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00985127 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Hawaii, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial