E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018627 |
E.1.2 | Term | Gout |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principal research objective is to compare the effectiveness of two licensed drugs, which are frequently prescribed within primary care, to reduce pain from acute gout; namely low-dose colchicine and naproxen. |
|
E.2.2 | Secondary objectives of the trial |
The secondary research objectives are: • To compare the side-effects of two drugs (namely low-dose colchicine and naproxen), which are commonly prescribed to treat acute gout in primary care. • To compare the cost-effectiveness of low-dose colchicine and naproxen for the treatment of acute gout in primary care • To compare whether patients take each drug as prescribed • To compare the time taken for low-dose colchicine and naproxen to reduce pain in patients with acute gout.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adults aged 18 years and over • Consultation with their GP, primary care out-of-hours service or walk-in-centre that is approved for the trial. • Current attack of acute gout (first attack or recurrent). The diagnosis of gout will be made on clinical grounds and will not require joint aspiration, blood tests, imaging or clinical criteria. • Patient has capacity and willingness, in the view of the recruiting clinician, to give consent and complete the trial paperwork, including the symptom diary.
|
|
E.4 | Principal exclusion criteria |
• Known unstable medical conditions (such as ischaemic heart disease, impaired liver function) • Known stage 4/5 kidney disease (eGFR/creatinine clearance <30ml/min) • Recent surgery of gastrointestinal bleed • History of gastric ulcer • Current anticoagulant use • Allergy to aspirin/NSAID • Previous inability to tolerate naproxen or low-dose colchicine • Other contraindication to either study drug in accordance with the Summary of Product Characteristics (SPC) supplied in the Investigator Site File • Prescription of naproxen or colchicine in the previous 24 hours • Pregnant or lactating females • Potentially vulnerable individuals • Previous participation in the CONTACT trial during a previous acute attack of gout. • Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is the change in a 0-10 worst pain intensity numeric rating scale. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary outcome measure will be measured over days 0-7. |
|
E.5.2 | Secondary end point(s) |
• the proportion of participants in each group reporting complete resolution of pain and time to treatment effect. • side-effects (nausea, vomiting, dyspepsia, diarrhoea and abdominal pain) via a self-reported drug side-effect questionnaire • patient global assessment of response to treatment • use of other medications for pain relief (for example, steroids, paracetamol, opiates) • adherence to naproxen/low-dose colchicine • relapse/recurrence of acute gout • EQ-5D 5-L, healthcare utilisation (re-attendance at GP/accident and emergency/primary care out-of-hours service), time off work/education
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoints will be measured over 4 weeks. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 100 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last participants' last data item received. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |