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Anti-gout agent
D-0120 + Allopurinol for Gout
Phase 2
Recruiting
Research Sponsored by InventisBio Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial tests a new drug, D-0120, with an existing one (Allopurinol) to treat Gout in adults.
Who is the study for?
Adults with gout who've had at least 2 flares in the past year can join this trial. They need to have a BMI between 18 and 40, respond poorly to urate-lowering treatments, and pass certain lab tests. Participants must not be pregnant or breastfeeding, have serious other illnesses, recent cancer history, or any condition that could risk their safety or affect study results.Check my eligibility
What is being tested?
The trial is testing D-0120 combined with Allopurinol for gout treatment. It's a Phase II study which means they're looking at how well it works and checking its safety in people who meet specific health criteria.See study design
What are the potential side effects?
While the side effects of D-0120 are not detailed here, common side effects from similar medications may include stomach issues, rash, fatigue. Allopurinol can cause skin reactions, gastrointestinal discomfort and rarely more severe conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
• To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment2 Interventions
week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol
Group II: Cohort AExperimental Treatment2 Interventions
week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D-0120
2019
Completed Phase 2
~140
Allopurinol
1999
Completed Phase 4
~6150
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Who is running the clinical trial?
InventisBio Co., LtdLead Sponsor
19 Previous Clinical Trials
1,879 Total Patients Enrolled
1 Trials studying Gout
39 Patients Enrolled for Gout
Kathryn StazzoneStudy DirectorInventisBio Co., Ltd
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control during and for 30 days after the study.I am not pregnant or breastfeeding.I have gout and my current treatment isn't lowering my uric acid levels enough.I have experienced at least 2 gout attacks in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B
- Group 2: Cohort A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study accept elderly participants aged 85 and over?
"Participants in this trial must be of legal age and below 75 years old."
Answered by AI
What is the aggregate number of participants involved in this clinical experiment?
"Affirmative. The data located on clinicaltrials.gov states that this scientific experiment, which was initially published on April 17th 2023, is actively recruiting participants. A total of 80 individuals need to be enrolled from 1 medical site."
Answered by AI
Is it feasible to become part of this clinical trial?
"Candidates who have gout and are between the ages of 18 to 75 can qualify for this trial. The research team is actively seeking 80 participants in total."
Answered by AI
Has Cohort A been granted the official consent of the FDA?
"Our safety score for Cohort A is 2 out of 3, given there are some studies suggesting it's safe but insufficient evidence exists to conclude the drug has efficacy."
Answered by AI
Are there still slots available for participation in this trial?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively enlisting volunteers from 1 site and a total of 80 participants are needed for the study; its posting date was April 17th 2023 with an update on May 3rd 2023."
Answered by AI
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