E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The condition under investigation is cancer induced bone pain (CIBP). This is a major cause of morbidity in patients with cancer and unfortunately standard treatments (including radiotherapy) can be in-effective or limited by side effects.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027452 |
E.1.2 | Term | Metastases to bone |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10033372 |
E.1.2 | Term | Pain and discomfort NEC |
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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 establish if radiotherapy and pregabalin gives superior analgesia in CIBP than radiotherapy alone. |
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E.2.2 | Secondary objectives of the trial |
The trial will also assess the IMP effect on:
· Background, spontaneous and movement-related pain · Total opioid requirements, ie background and breakthrough doses · Global quality of life scores (Euroqol thermometer) · HAD scores · Changes in sensory responses as assessed by Quantitative Sensory Testing (QST). · Opioid side-effects · Withdrawal from study
Both the tolerability and any serious adverse events of the IMP will also be assessed
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Clearly identifiable bone pain · Index bone pain ³ 4/10 · Written informed consent · Age ³ 18 years · Able to complete necessary assessments required as part of the trial · Life expectancy > 2 months · Due to receive palliative radiotherapy for bone pain
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E.4 | Principal exclusion criteria |
· Age < 18 years · Current gabapentin/pregabalin use · Significant renal impairment (plasma creatinine >1.5mg/ml, creatinine clearance< 60 mmls/hr) · Change in any tumoricidal therapy before entering the study which may be expected to have an analgesic benefit during the study period · Patients receiving bisphosphonates purely as an analgesic regimen which may be expected to have effects during the study period. (Patients on regular bisphosphonates pre occurrence of current bone pain allowed.) · Bed bound patients · Patients who are having palliative radiotherapy to vertebral metastases · Patients receiving wide-field irradiation
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the proportion of patients improving in the placebo arm and the active arm where an improvement is defined as a reduction of two or more points on the pain scale between baseline at the start of the “Assessment” period and end of study. The pain measured here is the worst pain in the last 24 hours at the two assessment points. In addition, the two point reduction needs to be accompanied by a stable or reduced opioid dose compared to the “Assessment” period baseline dose. |
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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 | Yes |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 4 |
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 | Information not present in EudraCT |
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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For the purposes of Clinical Trial Authorisation the trial is deemed to have ended 30 days after the last patient remaining on treatment receives the last dose of Pregabalin or Placebo.
For the purposes of the Main REC approval, the study end date is deemed to be the date of the last data capture.
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |