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

Phase 1

• Conditions: Patients with ranula.; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2012-004540-29-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-11
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified