E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
trattamento del dolore oncologico episodico intenso (Breakthrough Cancer Pain, BTCP,) nei soggetti in terapia analgesica con oppioidi assunta regolarmente |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058019 |
|
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 primary objective of the study is to investigate the long-term safety, tolerability, and
acceptability of Nasalfent in the treatment of BTCP. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
If enrolled in Studies CP043/06/FCNS or CP044/06/FCNS:
a. Subject successfully completed the study (including the return of any
remaining drug supplies and successful completion of the subject
diaries).
b. Subject is continuing to experience episodes of breakthrough pain
that were adequately controlled with a designated dose of Nasalfent
in Studies CP043/06/FCNS or CP044/06/FCNS.
c. The subjectメs medical condition is such that the subject continues to
meet the other inclusion/exclusion criteria listed.
If newly enrolled into this study:
Male or female subjects, aged 18 years and older, with a malignancy
who are taking regular, 24-hour medication (at least 60 mg oral
morphine or equivalent opioid) for his or her underlying persistent
cancer pain and who typically have 1 to 4 episodes of BTCP per day
are eligible for participation |
|
E.4 | Principal exclusion criteria |
Subjects with uncontrolled or rapidly escalating pain or whose condition
is unstable or rapidly deteriorating should not be enrolled. Additionally,
subjects with a medical condition (i.e., respiratory, cardiac, hepatic or
renal, neurological, psychiatric) that would make them unsuitable for
the study should not be enrolled. Subjects with a history of alcohol or
substance abuse are not eligible. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Withdrawal due to AEs.
Physical examination, including vital signs.
Laboratory assessments.
Subject acceptability assessments. |
|
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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |
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 | 5 |