GoutPhase 2NCT06995339
Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients
A Phase 2 study testing Febuxostat Tablets and Metformin in people with Gout, run by Mostafa Bahaa at 1 site in Egypt.
Trial summary
Gout is a systemic disease that results from the deposition of monosodium urate crystals (MSU) in tissues. Increased serum uric acid (SUA) above a specific threshold (>6.8 mg/dl) is a requirement for the formation of uric acid crystals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gout
- What is being tested?
- Febuxostat Tablets and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2025to 30 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged < 18 years.
- All patients are diagnosed to have gout with serum uric acid < 7 mg/dl.
- All patients are diagnosed to have obesity with body mass index (BMI) ≥ 30 kg/m2.
Who cannot join
- The presence of any type of diabetes mellitus.
- Patients with drug-induced hyperuriceamia (those taking anti-TB agents, low dose aspirin, cytotoxic chemotherapy, diuretics, immunosuppressants, fructose, lactate infusion, testosterone or xylitol).
- Non-obese patients with BMI >30 kg/m2.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostate on Gouty Obese Non-Diabetic Patients
Gout is a systemic disease that results from the deposition of monosodium urate crystals (MSU) in tissues. Increased serum uric acid (SUA) above a specific threshold (>6.8 mg/dl) is a requirement for the formation of uric acid crystals. MSU crystals can be deposited in all tissues mainly in and around the joints forming tophi. Early presentation of gout is an acute joint inflammation that is quickly relieved by non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Lowering SUA levels below deposition threshold either by dietary modification or using serum uric acid lowering drugs is the main goal in management of gout. This results in dissolution of MSU crystals preventing further attacks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Febuxostat TabletsDrug
Febuxostat is a selective xanthine oxidase inhibitor (XOI) that targets uric acid generation. It has been used as a SUA lowering agent in patients not responding to allopurinol
MetforminDrug
Metformin is an oral antihyperglycemic drug widely used in type 2 diabetes (T2DM) treatment. Most of its effects are exerted via an indirect induction of the phosphorylated activation of AMP-activated protein kinase (AMPK)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | patients will receive febuxostat 80 mg daily for 6 months. Receives: Drug: Febuxostat Tablets |
| Metformin group | Active comparator | patients will receive metformin 1000 mg daily for 6 months Receives: Drug: Febuxostat Tablets; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum uric acid level
Serum uric acid is the major metabolite of purine pathway and used in diagnosis of gouty patients
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 posted29 May 2025
- Study start30 May 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mostafa Bahaa
- Sponsor type
- University, hospital or other
- Collaborators
- Dalia Naser Abdel-Sadek Safa , Faculty of Pharmacy, Tanta University, Sahar Mohamed Elhaggar, Faculty of Pharmacy, Tanta University, Al-Azhar University
- Responsible party
- Sponsor-investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995339
- Sponsor's protocol ID
- 58479
- Status last verified
- Sep 2026
- First submitted
- 20 May 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No