NCT02287818

Brief Summary

The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 28, 2020

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

November 6, 2014

Results QC Date

October 5, 2020

Last Update Submit

June 2, 2022

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

  • Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL

    8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo plus Febuxostat

Drug: PlaceboDrug: Febuxostat

AC-201

EXPERIMENTAL

AC-201 CR tablet plus Febuxostat

Drug: AC-201Drug: Febuxostat

Interventions

PlaceboDRUG

Placebo twice daily from Day 1 to Week 12

Also known as: PBO
Placebo
AC-201DRUG

AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12

Also known as: AC-201 CR tablet
AC-201
FebuxostatDRUG

Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL

Also known as: ULT
AC-201Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female age 20 to 65 years, inclusive.
  • Meets ≥6 of the 12 American College of Rheumatology preliminary criteria (1977) for the classification of acute arthritis of primary gout (Appendix 2), OR have proven tophus or documented monosodium urate (MSU) crystals in the joint fluid.
  • Serum uric acid ≥7.5 mg/dL and ≤10 mg/dL at screening with ≥1 gouty arthritis flare within one year prior to screening, OR serum uric acid ≥9 mg/dL and ≤10 mg/dL at screening with or without prior gout flares.

You may not qualify if:

  • Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2 weeks prior to screening.
  • Occurrence of a gouty arthritis flare within 1 week prior to screening or during the screening period through baseline.
  • Use of colchicine within 1 week prior to screening.
  • Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.
  • Allergy, contraindication, or intolerance to febuxostat.
  • Severe renal impairment.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration \>2 times the upper limit of laboratory normal range (\>2x ULN) at screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veteran General Hospital (TVGH)

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Gout

Interventions

diacereinFebuxostat

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
JingYi Lee
Organization
TWi Biotechnology Inc.
jingyi.lee@twibiotech.com
886-2-26571788

Study Officials

  • Chang-Youh Tsai

    Taipei Veteran General Hospital (TVGH)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 11, 2014

Study Start

December 1, 2014

Primary Completion

October 27, 2016

Study Completion

October 27, 2016

Last Updated

June 28, 2022

Results First Posted

October 28, 2020

Record last verified: 2022-06

Locations

TW(1)