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Arthritis Research UK Gout Treatment Trial - Phase 2

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ClinicalTrials.gov Identifier: NCT01477346
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : January 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Gout Other: Nurse intervention Other: Standard care

Study Design

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
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Gout
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01477346


Locations
United Kingdom
Academic Rheumatology, University of Nottingham
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
University of Nottingham
Arthritis Research UK
Investigators
Principal Investigator: Michael Doherty, MA MD FRCP University of Nottingham
More Information

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01477346     History of Changes
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:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases