Arthritis Research UK Gout Treatment Trial - Phase 2

NCT ID: NCT01477346

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

517 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gout

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nurse intervention

Nurse led package of care based on current recommended best practice.

Group Type OTHER

Nurse intervention

Intervention Type OTHER

Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.

Standard care

Continuing standard general practitioner led care

Group Type OTHER

Standard care

Intervention Type OTHER

Continuing standard General Practitioner led care.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nurse intervention

Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.

Intervention Type OTHER

Standard care

Continuing standard General Practitioner led care.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arthritis Research UK

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Doherty, MA MD FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Academic Rheumatology, University of Nottingham

Nottingham, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Stamp LK, Frampton C, Morillon MB, Taylor WJ, Dalbeth N, Singh JA, Doherty M, Zhang W, Richardson H, Sarmanova A, Christensen R. Association between serum urate and flares in people with gout and evidence for surrogate status: a secondary analysis of two randomised controlled trials. Lancet Rheumatol. 2022 Jan;4(1):e53-e60. doi: 10.1016/S2665-9913(21)00319-2. Epub 2021 Nov 5.

Reference Type DERIVED
PMID: 38288731 (View on PubMed)

Doherty M, Jenkins W, Richardson H, Sarmanova A, Abhishek A, Ashton D, Barclay C, Doherty S, Duley L, Hatton R, Rees F, Stevenson M, Zhang W. Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1403-1412. doi: 10.1016/S0140-6736(18)32158-5.

Reference Type DERIVED
PMID: 30343856 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11115

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nurse-Led Telehealth for Gout
NCT06971146 RECRUITING NA
Center of Research Translation (CORT) Project 2
NCT02038179 COMPLETED PHASE2/PHASE3