Injection treatment of ranula with OK 432 - A prospective, randomized, placebo controlled, double-blind study

INTERVENTION: Trade Name: Picinabil Injection (OK432) Product Name: Picinabil Product Code: 874299 Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Route of administration not applicable CONDITION: Patients with ranula. Therapeutic area: Diseases [C] ‐ Ear, nose and throat diseases [C09] PRIMARY OUTCOME: Main Objective: Can treatment with OK‐432 be an effective alternative to surgey in patients with ranula? Primary end point(s): The size of ranula. Secondary Objective: To those patients experiencing an infection after the injection with OK‐432, how discomforting (self rated) do they experience it, compared to those patients in who have had experienced surgery? ; Timepoint(s) of evaluation of this end point: To be examined at 3‐4 times after first injection (dependent on whether patients recieve a secondary injection or not):; Day 70; Day 140; Month 10; Month 16 SECONDARY OUTCOME: Secondary end point(s): 1. local inflammatory reaction ; 2. QoL ; Timepoint(s) of evaluation of this end point: Day 1 ; Day 5 ; Day 70 ; Day 71 ; Day 75 ; Day 140 ; Month 10 ; Month 16 INCLUSION CRITERIA: 1. Men and women with ranula, aged 7 years and above 2. Be able to understand (if children <18: both parents understand) study concepts and comply to study visits and signed informed consent (both parents must sign informed consent if patient is yonger than 18 years old). Are the trial subjects under 18? yes Number of subjects for this age range: 8 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2