GoutPhase 2NCT06924658
Metformin in Safety and Efficacy in Gouty Patients
A Phase 2 study testing Metformin in people with Gout, run by Mostafa Bahaa at 1 site in Egypt.
Trial summary
The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gout
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2025to 20 Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout.
Who cannot join
- Systemic disorders such as cardiovascular, neurological, coronary artery disease.
- Hypertension, hyperlipidemia, diabetes mellitus, active infections.
- Other inflammatory or autoimmune diseases.
- Patients on biologics,
- Cases with hypersensitivity to metformin and those with impaired liver and kidney functions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta Unuversity
Tanta, 31527
Mostafa M I Bahaa, PhD, 0201025538337, mbahaa@horus.edu.eg
Mostafa M Bahaa, PhD
About this study
Official title: the Impact of Metformin Use on Clinical Outcomes in Gouty Patients
The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Placebo will have the same look of metformin
MetforminDrug
Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | this group will receive placebo in addition to the traditional lines of treatment of gout. Receives: Other: placebo |
| Metformin group | Active comparator | This group will receive metformin (1000mg/day) in addition to the traditional lines of treatment of gout. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Clinical assessment of disease activity
- Clinical assessment of disease activity by assessing patient and physician VAS visual analog scale (0-10 cm);
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start20 Apr 2025
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mostafa Bahaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924658
- Sponsor's protocol ID
- 8746
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No