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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004540-29-SE

Enrollment

Registered

2013-02-11

Start date

2013-05-24

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with ranula.

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women with ranula, aged 7 years and above 2. Be able to understand (if children =65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: 1. Younger than 7 years old. 2. Allergy to study drug excipients 2. Allergy to pencillin 3. Pregnant or breastfeeding (or are about to plan pregnancy) 4. Are dependent on immunomodulating substances, e.g.cytostatics. 5. Are dependent on corticosteroids (systemic use ) or regulary use of antiinflammatory drugs. 6. Have any reason, which in the opinion of the Principal Investigator would prevent the subject from safely participate in the study or complying with the protocol.

Design outcomes

Secondary

Measure	Time frame
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	—

Primary

Measure	Time frame
Main Objective: Can treatment with OK-432 be an effective alternative to surgey in patients with 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? ;Primary end point(s): The size of ranula.;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	—

Measure

Time frame

Main Objective: Can treatment with OK-432 be an effective alternative to surgey in patients with 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? ;Primary end point(s): The size of ranula.;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

—

Countries

Sweden

Contacts

Public ContactPrinciple Investigator

Karolinska University Hospital

malin.a.wendt@sll.se+46(0)704582574

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026