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GoutPhase 2NCT02330796

Bucillamine for the Treatment of Acute Gout Flare in Subjects With Moderate to Severe Gout

A Phase 2 study testing Bucillamine and Colchicine in people with Gout, run by Revive Therapeutics, Ltd. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of two doses of Bucillamine compared with low-dose Colchicine in the treatment of patients with acute gout flare. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gout
What is being tested?
Bucillamine and Colchicine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
3 sitesUnited States
Study dates
Apr 2015to Nov 2015
Phase
Phase 2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must present with confirmed diagnosis of gout, meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout
  • Subjects must have experienced at least one (1) acute gouty arthritic attack in the 12 months prior to randomization
  • Presence of acute gout flare for no longer than 3 days at Visit 2
  • Pain intensity at inclusion (Visit 2) of 7-10 on 11-point PI-NRS (defined as severe gout flare for this study)
  • All patients should not have contraindications for Colchicine use
  • Subjects with a history of intolerance to NSAIDs (Checklists Checklist 1)
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  • Subjects with significant medical contraindication to NSAIDs (Checklist 2)
  • Subjects with past failure of NSAIDs to control acute gouty arthritis attacks in the previous 12 months (Checklist 3)
  • Regarding significant medical contraindication to NSAIDs or past failure of NSAIDs to control acute gouty arthritis attacks in the previous 12 months (i.e. refractoriness to NSAIDs) the patient must meet one of below criteria:
  • At least one historical episode within the previous 12 months of being refractory or intolerant to NSAIDs that makes the physician concerned to use NSAIDs for a subsequent acute gout attack
  • The current (referring) physician judgment is that NSAIDs are not appropriate for treating the patient's gouty arthritis flare which may be due to changes in patient status such as worsening co-morbid conditions or co-medications (e.g., GI tract disease, renal insufficiency, hypertension, fluid retention, concurrent use of diuretics and/or an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, especially in CKD)
  • Subjects must be willing and able to give written informed consent. A HIPAA and/or state privacy consent must also be signed
  • Subjects must be able to swallow tablets
  • Use of permitted concomitant medications must be unchanged in dose and or frequency, 30 days prior to screening
  • Adequate organ function, evidenced by the following laboratory results within 90 days prior to randomization (historical lab results are acceptable).
  • Creatine clearance > 45 mL/min based on Cockroft-Gault glomerular filtration rate (GFR) estimation
  • For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of conception.

Who cannot join

  • Subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of infectious/septic arthritis, acute polyarticular gout (4 or more joints), with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion
  • Subjects who have experienced >2 acute gouty arthritic attacks per month, or >12 attacks overall, in the 6 months prior to randomization
  • Subjects with a history of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting within the previous 6 months prior to screening
  • Subjects with a Body Mass Index >45 kg/m2; calculated as body weight (kg)/height (m)2 at Screening Visit
  • Subjects with acute or chronic infections including known HIV and/or Hepatitis B or C
  • Uncontrolled hypertension (>160/90 mmHg seated) (if the first set of BP assessment meets the definition of uncontrolled hypertension, a second set of BP assessments may be performed after the patient has rested for at least 30 min. If the second set of BP assessments does not meet the definition of uncontrolled hypertension the patient will be eligible for participation)
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  • Subjects with proteinuria ≥1+ or ≥30 mg on dipstick urinalysis that is confirmed on repeat assessment within 24 hours
  • Subjects with significant heart failure and activity impairment (Class III-IV of the New York Heart Association (NYHA)
  • Subjects with any history of malignancy, 5 years prior to randomization
  • Subjects with CKD NKF stages 3B -5 chronic renal dysfunction (eGFR <45 mL/min/1.73m2 acc. to Cockcroft Gault formula)
  • Subjects with serious hepatic disorder (Child-Pugh scores B or C)
  • Subjects who have not washed out of dopamine antagonists or depleting drugs excluding anticholinergics and/or antihistamines with anticholinergic effects at least 14 days prior to Day 1 (Visit 2)
  • Subjects with a documented history of alcohol or substance abuse within the 12 months prior to randomization(consumption of >21 units of alcohol per week is considered alcohol abuse)
  • Subjects with significant CNS effects including vertigo and dizziness

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Texas Physicians Research Medical Group

    Arlington, Texas, 76015

  • Sun Research Institute

    San Antonio, Texas, 78215

  • West Coast Research

    San Roman, California, 94582

Other trials in United States

About this study

Official title: A RANDOMIZED, MULTICENTRE PHASE IIa OPEN-LABEL, ACTIVE-COMPARATOR TRIAL TO ASSESS THE EFFICACY AND SAFETY OF TWO REGIMENS OF BUCILLAMINE 100 MG TABLETS AS COMPARED TO COLCHICINE 0.6 MG TABLETS FOR THE TREATMENT OF AN ACUTE GOUT FLARE IN SUBJECTS WITH MODERATE TO SEVERE GOUT.

A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of two doses of Bucillamine compared with low-dose Colchicine in the treatment of patients with acute gout flare.

Read the detailed description

To evaluate the safety and tolerability of two regimens of Bucillamine 100 mg (900 mg and 1,800 mg) over seven days of treatment compared with Colchicine 0.6 mg (1.8 mg) in the treatment of patients with acute gout flare

Conditions
Gout
Being tested
Bucillamine, Colchicine
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BucillamineDrug

    Bucillamine Tablets

  • ColchicineDrug

Study groups in NCT02330796
Study groupRoleWhat they receive
Arm AExperimentalBucillamine (900 mg total dose over 7 days)
Receives: Drug: Bucillamine
Arm BExperimentalBucillamine (1,800 mg total dose over 7 days)
Receives: Drug: Bucillamine
Arm CActive comparatorColchicine (1.8 mg total dose in 2 doses taken 1 hour apart)
Receives: Drug: Colchicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite measure of adverse events (AEs), physical examinations, electrocardiograms (ECGs), vital signs, clinical laboratory evaluations, medical history, and prior/concomitant medications

    Measured: 7 days

  2. At least a 50% reduction in target joint pain PI-NRS score from baseline without using rescue drug

    Measured: 72 hours

Secondary outcomes (1)

  1. A greater than or equal to 50% reduction in target joint pain PI-NRS score from baseline at 24 hours and 48 hours post-dose without using rescue drug

    Measured: 24 hrs and 48 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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
Factorial
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02330796
Sponsor's protocol ID
REV-201
Status last verified
Oct 2016
First submitted
31 Dec 2014
Last updated
5 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bucillamine and Colchicine in people with Gout, run by Revive Therapeutics, Ltd. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite measure of adverse events (AEs), physical examinations, electrocardiograms (ECGs), vital signs, clinical laboratory evaluations, medical history, and prior/concomitant medications (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02330796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.

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