E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To further investigate the efficacy and safety of buprenorphine in the treatment of chronic pain compared to buprenorphine/naloxone.
The primary endpoint of the study will be area under the Visual Analogue Score (VAS) for pain versus time curve 0-6 hours. |
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E.2.2 | Secondary objectives of the trial |
Secondary efficacy endpoints are listed in section 11.4 of the final protocol. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
i) Written informed consent. ii) Male or female patients aged 18 years or over. iii) Patients with a recognised chronic pain condition greater than 3 months duration that has been diagnosed by a pain management specialist. iv) Patients with moderate to severe chronic pain (defined as a minimum of 40 mm pain score on the 100mm pain visual analogue scale at screening and a minimum average daily pain score of 4 on an 11-point Likert scale (0, no pain; 10, worst pain ever experienced) during pre-treatment. v) Adequate renal function (serum creatinine females <130 micro mol/l: males <150 micro mol/l). vi) Liver enzymes (AST or ALT) less than twice the upper limit of normal. Alkaline phosphatase less than twice the upper limit of normal. vii) Bilirubin within the normal range. viii) Patients stabilised on regular doses of step II analgesics for at least 2 weeks prior to the pre-treatment period of the study. Regular doses of analgesia must be continued during the study period (except for the two treatment days).
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E.4 | Principal exclusion criteria |
i) Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy). ii) Patients receiving sustained-release formulations of opioid analgesics or tramadol. iii) Patients who have a history of experiencing intolerable opioid analgesic side effects. iv) Patients who are receiving tricyclic antidepressants, anticonvulsants, membrane stabilisers or steroids for the pain if the doses have not been stable for the 2 weeks prior to the pre-treatment period of the study or if doses are likely to change during the study. v) Patients who are receiving monoamine oxidase inhibitors, phenobarbital, carbamazepine, phenytoin, rifampicin, gestodene, troleandomycin, ketoconazole, norfluoxetine, ritonavir, indinavir or saquinavir. vi) Abnormal serum electrolytes, which in the investigators opinion would exclude the patient from this study. vii) Haemoglobin outside the normal limits and white blood cell count below the lower limit of normal or above 12 x 10^9/l. viii) Patients who have anxiety or depression to such a degree that the investigators judge that participation in the study would be detrimental to their mental health. ix) Patients who are unable to understand and complete assessment questionnaires in English and those unable to complete VAS scales. x) Concurrent surgery, radiotherapy, chemotherapy or nerve blocks and those who have received this treatment 4 weeks prior to the study. xi) Patients who are receiving, or have received buprenorphine based analgesia in the last 14 days. xii) Patients who have been in another clinical study within the last 3 months. xiii) Patients with a previous history of allergy or intolerance to buprenorphine, naloxone or paracetamol. xiiii) Patients who have been previously randomised into the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study will be the area under the Visual Analogue Score (VAS) for pain versus time curve 0-6 hours. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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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Refer to section 7.6 of the Final protocol 0602004
The end of study is defined as the last visit of the last patient undergoing the study. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |