AzTrials
AzTrials

GoutPhase 4LASSONCT01391325

Allopurinol Outcome Study

A Phase 4 study testing Allopurinol in people with Gout, run by Ardea Biosciences, Inc. at 173 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Gout
What is being tested?
Allopurinol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,735 participants
Where
173 sitesin 7 countries
Study dates
Jul 2011to Mar 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
  • Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
  • If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
  • Must have had at least 2 gout flares in the past year.

Who cannot join

  • Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
  • History or suspicion of drug abuse.
  • History of autoimmune disease requiring systemic treatment.
  • Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
  • History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
  • Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
Show all 13Show fewer
  • Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).
  • Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.
  • Kidney or other organ transplant.
  • Active peptic ulcer disease requiring treatment.
  • History of xanthinuria, active liver disease, or hepatic dysfunction.
  • If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
  • Known hypersensitivity or allergy to allopurinol.

Trial locations and contacts

173 sites in 7 countries.

173 sites in 7 countries

United States127 sites

  • Study site

    Addison, Illinois, 60101

  • Study site

    Albany, New York, 12206

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Anaheim, California, 92805

  • Study site

    Arlington, Virginia, 22205

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Birmingham, Alabama, 35242

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Brandenton, Florida, 34208

  • Study site

    Brandon, Florida, 33511

  • Study site

    Bringham, Alabama, 35216

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Calera, Alabama, 35040

  • Study site

    Carmichael, California, 95608

  • Study site

    Chandlers, Arizona, 85224

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45224

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Columbus, Ohio, 43203

  • Study site

    Covina, California, 91723

  • Study site

    Cumberland, Maryland, 21502

  • Study site

    Dallas, Texas, 75216

  • Study site

    Dallas, Texas, 75235

  • Study site

    Danbury, Connecticut, 06810

  • Study site

    Dayton, Ohio, 45417

  • Study site

    Denver, Colorado, 80220

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    East Brandenton, Florida, 34208

  • Study site

    Elizabethtown, Kentucky, 42701

  • Study site

    Endwell, New York, 13760

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Eugene, Oregon, 97402

  • Study site

    Evansville, Indiana, 47713

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fleming Island, Florida, 32003

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Frederick, Maryland, 21702

  • Study site

    Green Valley, Arizona, 85614

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Harrisburg, North Carolina, 28075

  • Study site

    Hartsdale, New York, 10530

  • Study site

    Hemet, California, 92543

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77088

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Hyannis, Massachusetts, 02601

  • Study site

    Irvine, California, 92618

  • Study site

    Irving, Texas, 75061

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Jacksonville, Florida, 32205

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jonesboro, Arizona, 72401

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Lancaster, Pennsylvania, 17601

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Little Rock, Arkansas, 72204

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90048

  • Study site

    Louisville, Kentucky, 40213

  • Study site

    Meridian, Idaho, 83646

  • Study site

    Mesquite, Texas, 75150

  • Study site

    Miami, Florida, 33135

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    Mission Viejo, California, 92691

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Monroe, Louisiana, 71203

  • Study site

    Morgantown, West Virginia, 26505

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Nashua, New Hampshire, 03060

  • Study site

    Newnan, Georgia, 30265

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oldsmar, Florida, 34677

  • Study site

    Olive Branch, Mississippi, 38654

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Orlando, Florida, 32804

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Pasadena, California, 91107

  • Study site

    Phoenix, Arizona, 85028

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Plant City, Florida, 33563

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Port Orchard, Washington, 98366

  • Study site

    Portland, Oregon, 97220

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Reno, Nevada, 89502

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Sacramento, California, 95816

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92108

  • Study site

    San Ramon, California, 94583

  • Study site

    Sanford, Florida, 32771

  • Study site

    Santa Maria, California, 93454

  • Study site

    Seattle, Washington, 98122

  • Study site

    South Traverse City, Michigan, 49684

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Spokane, Washington, 99208

  • Study site

    Spring Hill, Tennessee, 37174

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33606

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Weslake Village, California, 91361

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Wheaton, Maryland, 20902

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winter Haven, Florida, 33880

  • Study site

    Worcester, Massachusetts, 01605

  • Study site

    Zephyrhills, Florida, 33542

Other trials in United States

South Africa14 sites

  • Study site

    Bloemfontein, 9301

  • Study site

    Durban, 4037

  • Study site

    Durban, 4067

  • Study site

    Durban, 4092

  • Study site

    East London, 5201

  • Study site

    Johannesburg, 1724

  • Study site

    Johannesburg, 2113

  • Study site

    Paarl, 7646

  • Study site

    Pretoria, 0084

  • Study site

    Pretoria, 2000

  • Study site

    Rondebosch, 7700

  • Study site

    Stellenbosch, 7600

  • Study site

    Thabazimbi, 0380

  • Study site

    Worcester, 6850

Other trials in South Africa

Australia11 sites

  • Study site

    Birsbane, Queensland, 4152

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Daw Park, South Australia, 5041

  • Study site

    Heidelberg, Victoria, 3081

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Malvern East, VIC3145

  • Study site

    North Ballarat, Victoria, 3353

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Wollongong, New South Wales, 2522

  • Study site

    Woodville South, South Australia, 5011

Other trials in Australia

Canada7 sites

  • Study site

    Coquitlam, British Columbia, V3K 3P4

  • Study site

    Kelowna, British Columbia, V1Y 3G8

  • Study site

    Ottawa, Ontario, K1S 1L2

  • Study site

    Penticton, British Columbia, V2A 5C8

  • Study site

    Québec, Quebec, G1V 3M7

  • Study site

    Thornhill, Ontario, L4J 1W3

  • Study site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

New Zealand6 sites

  • Study site

    Auckland, 1010

  • Study site

    Christchurch, Canterbury, 8024

  • Study site

    Hamilton, 3240

  • Study site

    Papatoetoe, 2525

  • Study site

    Rotorua, 3010

  • Study site

    Tauranga, 3110

Other trials in New Zealand

Belgium5 sites

  • Study site

    Brussels, 1070

  • Study site

    Gozée, 6534

  • Study site

    Kortrijk, 8500

  • Study site

    Mouscron, 7700

  • Study site

    Yvoir, 5530

Other trials in Belgium

Germany3 sites

  • Study site

    Altenburg, 04600

  • Study site

    Dresden, 01307

  • Study site

    Eichstätt, 85072

Other trials in Germany

About this study

Official title: Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)

This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.

Conditions
Gout
Being tested
Allopurinol
Medical subject headings
Gout

What participants receive

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

  • AllopurinolDrug

    Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.

Study groups in NCT01391325
Study groupRoleWhat they receive
AllopurinolOtherTreatment.
Receives: Drug: Allopurinol

What is being measured

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

  1. Safety of Allopurinol

    Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.

    Measured: Every month for 6 months.

Secondary outcomes (3)

  1. Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL

    Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6.

    Measured: Month 6

  2. Incidence of Gout Flares

    Proportion of subjects who experienced at least one gout flare requiring treatment during the study.

    Measured: Every month for 6 months.

  3. Mean Change From Baseline to Month 6 in SF-36 PCS+MCS

    The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10.

    Measured: Month 6

Timeline

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

  1. First posted12 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2013
  4. Study completionMar 2013

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,735 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01391325
Sponsor's protocol ID
ALLO-401
Acronym
LASSO
Status last verified
May 2014
First submitted
7 Jul 2011
Last updated
17 Jun 2014
Data monitoring committee
No

Publications

  • Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.

    PubMed 35835008

  • Becker MA, Fitz-Patrick D, Choi HK, Dalbeth N, Storgard C, Cravets M, Baumgartner S. An open-label, 6-month study of allopurinol safety in gout: The LASSO study. Semin Arthritis Rheum. 2015 Oct;45(2):174-83. doi: 10.1016/j.semarthrit.2015.05.005. Epub 2015 May 21.

    PubMed 26190562

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Allopurinol in people with Gout, run by Ardea Biosciences, Inc. at 173 sites in 7 countries.

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 4 inclusion and 13 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United States, South Africa, Australia, Canada, New Zealand and 2 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety of Allopurinol (time frame: Every month for 6 months.). 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 NCT01391325, which also lists 2 linked publications.

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 17 Jun 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in