E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mandibular osteoradionecrosis occuring from radiation treatment of cancer.
No healthy volunteers |
Osteoradionekrose |
|
E.1.1.1 | Medical condition in easily understood language |
Osteoradionecrosis |
Osteoradionekrose |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064658 |
E.1.2 | Term | Osteonecrosis of jaw |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 evaluate the effect of hyperbaric oxygen treatment on mandibular osteoradionecrosis. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate effect of hyperbaric oxygen treatment on life quality in osteoradionecrosis patients. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Osteoradionecrosis grade 2, 3 or 4 (CTCAE v 3.0.)
2. Localization: Mandibula
3. Age over 18 yrs old
|
|
E.4 | Principal exclusion criteria |
1. Malignant diseases that may affect the course of the treatment or disease
2. Previous HBO treatment for osteoradionecrosis
3. Pregnancy
4. Uncontrolled hypertension
5. Lack of ability to equalize the pressure in the the ears and sinuses, although incision or drain of the tympanic membrane is an accepted adjunctive measure
6. Claustrophobia
7. Pneumothorax
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint recovery from osteoradionecrosis as defined by the NCI Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Recovery is defined as no signs of osteoradionecrosis according to these criteria or grade 1 on this scale.
Grade 0: No signs of disease
Grade 1: Asymptomatic, radiographic findings only.
Grade 2: Symptomatic and interfering with function, but not interfering with ADL (Activities of Daily Living). Minimal bone removal indicated i.e. minor sequestrectomy).
Grade 3: Symptomatic, interfering with ADL. Operative intervention or hyperbaric oxygen indicated.
Grade 4: Disabling
Grade 5: Death
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 week, 1 month, 3 months and 12 months |
1 uge, 1 måned, 3 måneder og 12 måneder |
|
E.5.2 | Secondary end point(s) |
Quality of life |
Livskvalitet |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 week, 1 month, 3 months and 12 months |
1 uge, 1 måned, 3 måneder og 12 måneder |
|
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 | 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 | 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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Behandling kontrol ingen behandling med HBO |
Treatment vs. no treatment |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
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 | 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
|
The trial is ended when participant no. 114 has finished participation. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 11 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 11 |
E.8.9.2 | In all countries concerned by the trial months | 6 |