Head-and-neck cancer patients suffering from radiation-indused oral mucositis MedDRA version: 9.1 Level: LLT Classification code 10037763 Term: Radiation mucositis
Conditions
Interventions
Product Name: CAM2028
Product Code: CAM2028
Pharmaceutical Form: Oromucosal solution
INN or Proposed INN: Benzidamine hydrochloride
CAS Number: 642-72-8
Current Sponsor code: CAM2028
Concentration uni
Sponsors
Camurus AB
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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).;Primary end point(s): - PID (pain intensity difference during 6 h after dosing) assessed via 0-10 Likert-pain score. | — |
Countries
Bulgaria
Outcome results
None listed