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Allopurinol

Phase 2

Gout | Small molecule | Metabolic |BioCryst Pharmaceuticals, Inc.|Last Updated: Jan 23, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment87

FDA Designations

No designations recorded

Clinical trial landscape

Allopurinol · 1 trial · 1 indication

Phase 2 1
NCT01129648Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/GoutGout
COMPLETED87 Analytics
PHASE2COMPLETED
Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout
GoutUnlock trial analytics

Study Endpoints

Primary Endpoints

To estimate the dose response relationship of BCX4208 when administered as a monotherapy and in combination with allopurinol on sUA.
Day 22
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BCX4208 placebo + Allopurinol placeboPLACEBO_COMPARATORAdministered daily for 21 days.
BCX4208 placebo + Allopurinol 100mgACTIVE_COMPARATORAdministered daily for 21 days.
BCX4208 placebo + Allopurinol 200 mgACTIVE_COMPARATORAdministered daily for 21 days.
BCX4208 Placebo + Allopurinol 300 mgACTIVE_COMPARATORAdministered daily for 21 days.
BCX4208 20 mg + Allopurinol PlaceboEXPERIMENTALAdministered daily for 21 days.
BCX4208 20 mg + Allopurinol 100 mgEXPERIMENTALAdministered daily for 21 days.
BCX4208 20 mg + Allopurinol 200 mgEXPERIMENTALAdministered daily for 21 days.
BCX4208 20 mg + Allopurinol 300 mgEXPERIMENTALAdministered daily for 21 days.
BCX4208 40 mg + Allopurinol placeboEXPERIMENTALAdministered daily for 21 days.
BCX4208 40 mg + Allopurinol 100 mgEXPERIMENTALAdministered daily for 21 days.
BCX4208 40 mg + Allopurinol 200 mgEXPERIMENTALAdministered daily for 21 days.
BCX4208 40 mg + Allopurinol 300 mgEXPERIMENTALAdministered daily for 21 days.
BCX4208 80 mg + Allopurinol PlaceboEXPERIMENTALAdministered daily for 21 days.
BCX4208 80 mg + Allopurinol 100 mgEXPERIMENTALAdministered daily for 21 days.
BCX4208 80 mg + Allopurinol 200 mgEXPERIMENTALAdministered daily for 21 days.
BCX4208 80 mg + Allopurinol 300 mgEXPERIMENTALAdministered daily for 21 days.

Interventions

NameTypeDescription
PlaceboDRUGAdministered daily for 21 days
AllopurinolDRUGAdministered daily for 21 days.
BCX4208DRUGAdministered daily for 21 days.
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Eligibility Criteria

Age Range18 Years to 69 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. Age ≥18 to \<70 years, with screening sUA \> 8.0 mg/dL. 2. Diagnosis of gout according to the criteria of the American Rheumatism Association (1977). 3. Be willing and able to take colchicine 0.6 mg per day or naproxen 250 mg twice daily (with proton pump inhibitor if needed)...

Countries:United States
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Frequently asked questions about Allopurinol

What is Allopurinol used for in gout?

Allopurinol is a small molecule being studied for the treatment of gout. It is a metabolic therapeutic that is being evaluated in combination with another investigational drug to lower serum uric acid levels. The drug is currently in Phase 2 clinical development for this indication.

Who makes Allopurinol?

Allopurinol is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gout.

What phase is Allopurinol in?

Allopurinol is in Phase 2 clinical development for the treatment of gout. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its serum uric acid-lowering activity, safety, and pharmacokinetic interaction.

What clinical trials is Allopurinol in?

Allopurinol has been studied in one completed Phase 2 clinical trial, identified as NCT01129648. This randomized, double-blind, placebo-controlled study enrolled 87 participants with gout in the United States to evaluate the serum uric acid-lowering activity, safety, and pharmacokinetic interaction of oral BCX4208 and Allopurinol.

Is Allopurinol the same as BCX4208?

No, Allopurinol is not the same as BCX4208. Allopurinol is the drug being studied, while BCX4208 is a separate investigational drug that was administered in combination with Allopurinol in the clinical trial. The study evaluated the interaction and combined effects of both drugs in subjects with gout.