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A Proof-of-Concept Study of AC-201 to Prevent Gout Flares

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01712204
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : December 1, 2014
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
TWi Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Gout Flares
Interventions Drug: Placebo
Drug: AC-201
Drug: Febuxostat
Enrollment 82
Recruitment Details Overall, 82 patients from 8 clinical centers participated in the study between 28 January 2013 to 04 September 2013.
Pre-assignment Details Participants were assessed at an initial screening visit within 2 weeks before the baseline visit.
Arm/Group Title Placebo AC-201
Hide Arm/Group Description Placebo Capsule BID for 16 Weeks AC-201 50mg Capsule BID for 16 Weeks
Period Title: Overall Study
Started 41 41
Completed 33 36
Not Completed 8 5
Reason Not Completed
Adverse Event             3             1
Withdrawal by Subject             3             3
Lost to Follow-up             1             0
Protocol Violation             1             1
Arm/Group Title Placebo Capsule BID AC-201 50mg Capsule BID Total
Hide Arm/Group Description Placebo Capsule BID for 16 Weeks AC-201 50mg Capsule BID for 16 Weeks Total of all reporting groups
Overall Number of Baseline Participants 41 41 82
Hide Baseline Analysis Population Description
A total of 82 subjects were randomized and received at least one dose of study medication (the Intent-to-Treat [ITT] Population). The ITT Population was used for baseline/demographic, disposition, and safety summaries. The ITT Population was the primary analysis set for efficacy analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 41 participants 82 participants
43.6  (11.8) 43.7  (12.6) 43.6  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
41
 100.0%
41
 100.0%
82
 100.0%
1.Primary Outcome
Title Number of Gout Flares Per Subject
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo AC-201
Hide Arm/Group Description:

Placebo Capsule BID for 16 Weeks

Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)

AC-201 50mg Capsule BID for 16 Weeks

Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)

Overall Number of Participants Analyzed 41 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: flares
3.02
(2.51 to 3.64)
2.45
(2.01 to 3.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, AC-201
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1356
Comments [Not Specified]
Method Possion regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.62 to 1.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.113
Estimation Comments [Not Specified]
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo AC-201
Hide Arm/Group Description

Placebo Capsule BID for 16 Weeks

Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)

AC-201 50mg Capsule BID for 16 Weeks

Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)

All-Cause Mortality
Placebo AC-201
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo AC-201
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/41 (2.44%)      0/41 (0.00%)    
Metabolism and nutrition disorders     
Frequent Gout Attack  1  1/41 (2.44%)  1 0/41 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Placebo AC-201
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/41 (26.83%)      10/41 (24.39%)    
Blood and lymphatic system disorders     
Anemia  1  0/41 (0.00%)  0 2/41 (4.88%)  2
Hepatobiliary disorders     
Hepatic function abnormal  1  3/41 (7.32%)  3 2/41 (4.88%)  2
Infections and infestations     
Nasopharyngitis  1  0/41 (0.00%)  0 2/41 (4.88%)  2
Investigations     
Blood CPK increased  1  4/41 (9.76%)  4 1/41 (2.44%)  1
ALT increased  1  3/41 (7.32%)  3 0/41 (0.00%)  0
Creatinine renal clearance decreased  1  0/41 (0.00%)  0 2/41 (4.88%)  2
Musculoskeletal and connective tissue disorders     
Tendonitis  1  1/41 (2.44%)  1 2/41 (4.88%)  2
Renal and urinary disorders     
Renal Impairment  1  1/41 (2.44%)  1 2/41 (4.88%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Director
Organization: TWi Biotechnology, Inc.
Phone: +886-2-26573350 ext 368
Responsible Party: TWi Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01712204     History of Changes
Other Study ID Numbers: AC-201-GOU-001
First Submitted: October 19, 2012
First Posted: October 23, 2012
Results First Submitted: November 24, 2014
Results First Posted: December 1, 2014
Last Update Posted: May 22, 2018