Arthritis Research UK Gout Treatment Trial - Phase 2
This study is currently recruiting participants.
Verified April 2013 by University of Nottingham
Sponsor:
University of Nottingham
Collaborator:
Arthritis Research UK
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01477346
First received: November 14, 2011
Last updated: April 4, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | November 14, 2011 | ||||
| Last Updated Date | April 4, 2013 | ||||
| Start Date ICMJE | March 2013 | ||||
| Estimated Primary Completion Date | November 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduction in serum uric acid levels [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01477346 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Arthritis Research UK Gout Treatment Trial - Phase 2 | ||||
| Official Title ICMJE | Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care | ||||
| 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). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Gout | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 724 | ||||
| Estimated Completion Date | November 2015 | ||||
| Estimated Primary Completion Date | November 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Inability to give informed consent and known terminal or mental illness |
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01477346 | ||||
| Other Study ID Numbers ICMJE | 19703 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Nottingham | ||||
| Study Sponsor ICMJE | University of Nottingham | ||||
| Collaborators ICMJE | Arthritis Research UK | ||||
| Investigators ICMJE |
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| Information Provided By | University of Nottingham | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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