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Arthritis Research UK Gout Treatment Trial - Phase 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01477346
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : January 5, 2017
Arthritis Research UK
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
The purpose of this study is to determine in community-derived patients with gout the effectiveness, and cost effectiveness, of a nurse-led complex intervention that reflects recommended best practice (including patient information concerning gout, its prognosis and its non-pharmacological and drug options).

Condition or disease Intervention/treatment Phase
Gout Other: Nurse intervention Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 517 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care
Study Start Date : March 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Arthritis Gout

Arm Intervention/treatment
Nurse intervention
Nurse led package of care based on current recommended best practice.
Other: Nurse intervention
Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.

Standard care
Continuing standard general practitioner led care
Other: Standard care
Continuing standard General Practitioner led care.

Primary Outcome Measures :
  1. Reduction in serum uric acid levels [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Reduction in number of self reported acute attacks during year 2 [ Time Frame: 2 years ]
  2. Improved Quality of Life scores at study end [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of gout
  • At least one acute attack of gout within previous 12 months

Exclusion Criteria:

- Inability to give informed consent and known terminal or mental illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01477346

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United Kingdom
Academic Rheumatology, University of Nottingham
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
University of Nottingham
Arthritis Research UK
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Principal Investigator: Michael Doherty, MA MD FRCP University of Nottingham
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Nottingham Identifier: NCT01477346    
Other Study ID Numbers: 11115
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases