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Study Summary
This trial aims to test the safety, effectiveness and dosing of a new medicine for gout and hyperuricemia, which is resistant to current treatments.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 280 Patients • NCT01709981Trial Design
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- I have gout that hasn't improved with standard treatments.My gout flare-up hasn't improved in the last 14 days.I have been on standard gout treatment for at least 4 weeks unless it was not suitable for me.I have never been diagnosed with gout before my screening visit.My kidney function is reduced, with specific test results.I am between 18 and 75 years old and agree to follow the study rules.I have been diagnosed with gout or have symptoms that meet gout criteria.I did not follow the prescribed gout medication plan during the initial trial phase.I haven't taken any medications that lower uric acid levels in the last 14 days.I am not pregnant, planning to become pregnant, or breastfeeding.Your body mass index (BMI) is between 19 and 40 at the screening visit.
- Group 1: SAP001 10 mg
- Group 2: SAP001 30 mg
- Group 3: SAP001 60 mg
- Group 4: Placebo versus SAP 001
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does the protocol for this study restrict enrollment to individuals under forty-five years old?
"Candidates who are of legal age and below traditional retirement age are eligible for recruitment into this clinical trial."
In what geographical areas can one access this clinical trial?
"This trial is enrolling participants from the Florida Site in Miami Lakes, FL, Miami Clinic in Miami, ID and Orlando Clinic in Orlando, MS; additional sites are also participating."
Who would be an ideal candidate for this clinical trial?
"Eligibility criteria for this clinical trial necessitate that applicants have gout and are between 18-65 years old. This study is enrolling a total of 80 participants."
Is there an ongoing recruitment process for this experiment?
"Clinicialtrials.gov verifies that the medical experiment is presently enlisting test subjects, having been first posted on December 12th 2022 and last updated on January 9th 2023."
What risks do participants of the SAP001 trial face in taking the first study drug group?
"SAP001's safety, which is supported by data from the phase 2 trial, was assigned a score of two. However, there are no available studies that suggest its efficacy."
How many participants can enroll in this medical experiment?
"Affirmative. According to information located on clinicaltrials.gov, this medical trial, which was first created on December 12th 2022 is still recruiting participants. A total of 80 patients are needed and 9 sites have been identified as possible locations for enrolment."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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