E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Head-and-neck cancer patients suffering from radiation-indused oral mucositis |
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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 | 10037763 |
E.1.2 | Term | Radiation mucositis |
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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 prove the local analgesic effect of a new formulation of BZD (CAM2028) over at least six hours after single dosing in patients with oral mucositis. |
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E.2.2 | Secondary objectives of the trial |
1. To assess the safety and tolerability of a single dose of a new formulation of BZD (CAM2028).
2. To assess the functional response to a single dose of trial medication in terms of difficulty in swallowing by a numerical score (0-10 Likert scale). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male/female patient ≥ 18 years of age. - Newly diagnosed head-and-neck cancer patients undergoing radiotherapy on an outpatient basis (at randomisation [Visit 2] patients must have received at least one third of the planned total dosage of radiation). - Symptomatic oral mucositis (WHO grade 2 or above) in week three to four of radiotherapy. - Assessment of pain by Likert scale (0-10) at screening (Visit 1), Visit 2 and 3 results in a score of at least 6 out of 10. - Written informed consent given freely after the nature of the study and disclosure of data has been explained to the patient.
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E.4 | Principal exclusion criteria |
- Patients receiving chemotherapy (previous or concurrent), immuno-therapy or previous radiation treatment to the upper airways - Patients undergoing radical or post-operative radiotherapy to a significant part of clinically visible (at least two anatomical sites at risk) oral and/or pharyngeal mucosa - Participation in another study of investigational drugs or devices parallel to, or less than 30 days before Visit 1, or previous enrolment in this study. - Employees of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, as well as family members of the employees or the investigator. - Pregnant or breast feeding woman. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at screening (Visit 1) and at Visit 2 and is routinely using adequate contraception prior to and during the trial and agrees not to attempt to become pregnant during the trial. A female of non-childbearing potential will be defined as one who has been post-menopausal for at least one year or has been surgically sterilised at least three months prior to the start of the trial or had a hysterectomy. - Known contraindications/hypersensitivity to trial drug and other NSAIDs (as judged by the investigator). - Conditions associated with a risk of poor protocol compliance (as judged by the investigator). - Any significant deviation of clinical relevance discovered during the screening examination or at Visit 2 (as judged by the investigator). - concomitant medical treatment other than allowed medication (local treatment of oral cavity; as judged by the investigator). - immunocompromised patients (including patients with HIV infection). - patients who suffer from hepatitis B and/or C infection. - any other significant clinical or laboratory condition or deviation which excludes the patient as appropriate for the study (as judged by the investigator).
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E.5 End points |
E.5.1 | Primary end point(s) |
- PID (pain intensity difference during 6 h after dosing) assessed via 0-10 Likert-pain score. |
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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 | No |
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 | Information not present in EudraCT |
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) | 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 | 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 | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |