ClinicalTrials.gg
CompletedNCT06995339Updated Sep 17, 2026

Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients

A Phase 2 interventional study of Febuxostat Tablets and Metformin in Gout, sponsored by Mostafa Bahaa. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Mostafa Bahaa · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Gout

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03

In context

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

This study's enrollment of 60 is below the median of 83 across 286 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Mostafa Bahaa is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (BMI) ≥ 30 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • The presence of any type of diabetes mellitus.
  • Patients with drug-induced hyperuriceamia (those taking anti-TB agents, low dose aspirin, cytotoxic chemotherapy, diuretics, , fructose, lactate infusion, testosterone or xylitol).
  • Non-obese patients with >30 kg/m2.
  • Pregnant or lactating women.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Control group

    patients will receive febuxostat 80 mg daily for 6 months.

    Drug: Febuxostat Tablets

  • Active comparator
    Metformin group

    patients will receive metformin 1000 mg daily for 6 months

    Drug: Febuxostat Tablets · Drug: Metformin

Interventions

  • 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

  • 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)

06

What researchers measure

Primary outcomes

  1. Change in serum uric acid level

    Serum uric acid is the major metabolite of purine pathway and used in diagnosis of gouty patients

    Time frame: 3 months

07

Study locations

1 site
  • Mostafa Bahaa
    Damietta, New Damietta 34518, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2025 to primary completion in Dec 2025, 7 months.

Of 30 phase 2 interventional studies under Gout, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2025
First posted
May 29, 2025
StartActual
May 30, 2025
Primary completionActual
Dec 30, 2025
CompletionActual
Dec 30, 2025
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06995339
Lead sponsor
Mostafa Bahaa
Collaborators
Dalia Naser Abdel-Sadek Safa , Faculty of Pharmacy, Tanta University, Sahar Mohamed Elhaggar, Faculty of Pharmacy, Tanta University, Al-Azhar University
Responsible party
Mostafa Bahaa (Lecturer, Tanta University) — Sponsor-investigator
First posted
May 29, 2025
Start date
May 30, 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025
Last update
Sep 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Metformin

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