E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
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 proposed study is based on the hypothesis that pain in hand osteoarthritis is due to local changes in the joint and the switching on of pain pathways in the brain that mediate chronic pain. The overall aim of this study is to determine whether drugs which influence central brain pain processing pathways can improve pain management in hand osteoarthritis. The primary objective of this study is to determine the effects of centrally acting drugs duloxetine and pregabalin versus placebo on pain perception in hand osteoarthritis using clinical pain scores. |
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E.2.2 | Secondary objectives of the trial |
The secondary research question in this study is to determine whether the drugs to be used in this study will change the perception of pain using local algometer testing of pain thresholds in the hand, wrists and sternum. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants fulfilling: 1.the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis, 2.right or left -handed 3.male or female 4.aged 40-75 5.On usual care for hand osteoarthritis including paracetamol and/or NSAIDs |
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E.4 | Principal exclusion criteria |
1. other rheumatological diagnosis e.g. rheumatoid arthritis 2. current or planned pregnancy 3. contraindications to duloxetine or pregabalin such as MAOI, SSRI, antidepressants, oral contraceptives, St John’s wort 4. history of depression 5. concomitant use of opioids including tramadol and pethidine 6. recent surgery i.e < 6 weeks prior to participation in the study 7. recent insertion of surgical implants i.e. less than 6 weeks before participation prior to entry 8. Previous use of duloxetine and/or pregabalin 9. uncontrolled hypertension 10. eGFR < 60 ml/min 11. hepatic impairment defined as ALT > 2.5 X ULN within 6 weeks of last clinical assessment 12. ischaemic heart disease 13. diabetes mellitus 14. regular use of alcohol or alcohol abuse(maximum limits are 28 units/week for men and 21 units/ week for women) 15. lactose intolerance |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be change in visual analogue score (VAS) for pain and the study is powered to detect statistically significant differences in change between groups. The VAS is a well-known method of rating pain on a continuous scale. Participants will be asked to score their VAS pain rating on a 0-100mm scale on a weekly basis which will be recorded in their diary card and CRF from week 1 to 13 weeks. Upon completion of the study, the change in VAS from baseline to 13 weeks will be used as the primary clinical endpoint for each participant. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The baseline VAS will be measured and then values post-treatment collected in each participant at weeks 4 and 13. |
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E.5.2 | Secondary end point(s) |
Clinical data analysis will include mean change in AUSCAN, neuropathic pain scores and pain threshold values using algometer readings from baseline to 13 weeks in the 3 groups across 30 joints per hand, both elbows and sternum. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Pain thresholds will be measured at baseline and then values post-treatment collected in each participant at week 13. |
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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 | Yes |
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
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The end of the trial will be the last study visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |