A double blind, randomized, placebo-controlled, three-arm, phase II study to investigate the safety and efficacy of oral glycyrrhizin (Glycyron® tablets) for the treatment of gingivitis - Glycyro

• Conditions: patients with gingivitis; MedDRA version: 9.1Level: LLTClassification code 10018292Term: Gingivitis

• Registration Number: EUCTR2008-008512-51-DE
• Lead Sponsor: onepharm Research & Development GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Adult male and female patients (aged 18 to 40 years)
Patients with gingivitis or mild periodontitis
Patients who have at least 4 teeth with GI = 1.5 per tooth at baseline
Patients with at least 20 teeth excluding the wisdom teeth
Patients must have read, understood and signed the informed consent form

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with systemic diseases
Patients chronically taking medication except contraceptives
Patients with moderate and severe periodontitis
Patients treated (more than 2 days) with antibiotics, steroidal and non-steroidal antiphlogistics less than 4 weeks prior to the baseline examination and/or such a treatment planned for the duration of the trial
Patients chronically treated with topical steroids
Patients who smoke or have been smoking more than 5 cigarettes a day during the last 6 months
Patients with known hypersensitivity or allergy to the test product and its ingredients, especially licorice, or to medications that have a similar chemical structure
Patients with hypertension (BP =139/89 mm Hg)
Patients with serum potassium values out of normal range (3.8 – 5.2 mmol/l)
Patients with serum sodium values out of normal range (136 -152 mmol/l)
Patients with clinically relevant signs of edema
Patients with known 11ß-HSD deficiency (syndrome of apparent mineralcorticoid excess)
Patients who regularly consume glycyrrhizin or licorice containing products (e.g. confectionary, teas, …)
Patients who have participated in another clinical study less than 4 weeks prior to the baseline examination
Female patients who are pregnant or breast feeding
Female patients of childbearing potential except those fulfilling the following criteria:
a.Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH >40mlU/ml)
b.Post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy)
c.Regular and correct use of contraceptives with a PEARL Index of < 1% (e.g. implants, depot formulations of hormones, oral contraceptives, intra uterine device – IUD)
d.Sexual abstinence
e.Partner who had vasectomy
Patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study,
Patients can be excluded at the principal investigators discretion

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to prove the efficacy of the IMP in the treatment of patients with gingivitis;Secondary Objective: Proof of safety<br>Determination of the proper dosage;Primary end point(s): Difference between the Gingival Index of Visit 4 and the one of Baseline Visit for 4 marker teeth