E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Cancer Pain |
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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 | LLT |
E.1.2 | Classification code | 10058019 |
E.1.2 | Term | Cancer pain |
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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 clinically meaningful equipotency ratios bewteen burpenorphine administered primarily transdermally and the strong opioids, morphine, oxycodone and fentanyl. |
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E.2.2 | Secondary objectives of the trial |
To confirm the absence of an analgesic ceiling effect with buprenorphine, across a broad range of pain severities, reflected by a wide range of daily doses of strong opioids; to confirm that the switch to buprenorphine is clinically effective and well-tolerated, and to address quantitative and qualitiative clinical differences in unwanted effects in order to provide a preliminary indication of the feasibility and any significant pharmaco-economic impact of switching from one strong opioid to another. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At Visit 1: 1. Males and females, 18 years or older. 2. Subjects who have given their written informed consent. 3. At baseline, female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test. 4. Subjects with moderate to very severe cancer pain, whose pain has been satisfactorily controlled over the preceding two weeks with a stable dose of strong opioid (see footnote 1) of at least 30mg morphine (or equivalent) per day. “Satisfactory control” is defined as recalled average daily pain scores as ≤ 4 on an 11-point Numerical Rating Scale (0=no pain, 10=worst pain imaginable) and strong opioid stability as taking a stable daily dose of sustained-release strong opioid (oral or patch) with no more than two doses of immediate release morphine [or equivalent] (or >30% of their 24 hour dose, whichever is greater) for breakthrough on average per day. At Visit 2: 1. To be eligible to receive Transtec®, subjects must have continued to obtain satisfactory pain control from the stable dose of strong opioid, with no more than two doses of immediate release morphine [or similar] (or >30% of their stable 24 hour dose, whichever is greater) for breakthrough on average for at least three consecutive days prior to starting on Transtec®.
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E.4 | Principal exclusion criteria |
1. Subjects who have previously failed on Transtec®, morphine or Temgesic® therapy. 2. Contraindications to Transtec®, morphine or Temgesic® as listed in their respective Summary of Product Characteristics. 3. Subjects with documented or suspected alcohol or drug abuse, or who are strongly suspected of having an addictive personality. 4. Subjects for whom a treatment is planned within the four week study period that could significantly alter the degree or nature of pain, e.g. radiotherapy, chemotherapy, hormonal therapy, biphosphonate therapy, surgery, nerve block, etc. 5. Subjects known to have a condition (e.g. hepatic or renal) that in the investigator’s judgement precludes participation in the study. 6. Subjects with a significant psychiatric disorder in the opinion of the investigator or subjects receiving strong anti-psychotic medication. 7. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry. 8. Subjects unable to comply with the study assessments and to complete the questionnaires. 9. Subjects who have previously been admitted to this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy response variable is the subjects' reported pain intensity in a diary card each day using an 11-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable). |
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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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | 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 | No |
E.8.1.1 | Randomised | No |
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 | 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 | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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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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 | 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 |