NCT02313883

A Phase I/II Study to Evaluate the Safety and Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis

A Phase I/II Study to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and Root Planing in Subjects With Periodontitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Geistlich Pharma AG · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

Summary

A Pharmacokinetic Pilot followed by a Phase I/II, Blinded, Randomized, Controlled, Parallel Arm Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and Root Planing in Subjects with Periodontitis

Detailed description

This trial will follow an adaptive trial design, whereby information regarding PerioSept(r) drug levels will be obtained via a PK trial lead in period (PK Pilot) in a limited number of subjects (up to N=8). This will be followed by the main safety and efficacy trial of PerioSept(r) as an adjunct to scaling and root planing (SRP) in subjects with moderate to severe periodontitis (Main Trial, N=87). The PK Pilot will be an open label PK study. Up to 8 qualifying subjects will receive SRP on Day 1 followed by 3% PerioSept(r) administered in a minimum of 4 qualifying periodontal Study Pockets in at least 2 quadrants with a probing pocket depth (PPD) ≥ 5mm and bleeding on probing (BOP) and at least 20 other qualifying pockets (PPD ≥ 5 mm). The Main Trial will be a multi-center, randomized, blinded, placebo controlled, parallel arm trial of PerioSept(r) (0.3%, 1% or 3%) administered up to three times (over Days 1 and 2, at Weeks 4 and 12) into a minimum of 4 qualifying periodontal Study Pockets in at least 2 quadrants with a PPD ≥ 5mm and BOP following SRP at baseline. All other eligible pockets with a PPD ≥ 5mm will also be treated. Full mouth SRP will be initiated on Day 1 followed by randomized treatment of that side. If necessary, SRP and randomized treatment may be completed on the other side of the mouth on Day 2. Treated pockets that still have a PPD ≥ 5mm at the 4 and 12 week visits will be retreated with SRP or SRP plus placebo or PS, as randomized. Assessments will be conducted over a 24 week (6 month) period including safety assessments and assessments of dental parameters (PPD, BOP, Plaque index, Gingival Index, Clinical attachment level).

Conditions

• Periodontitis

Interventions

Type	Name	Description
DRUG	PerioSept(r)	Taurolidine is derived from the amino acid taurine and has antimicrobial and immune modulating properties

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-07-02
• Completion: 2018-07-02
• First posted: 2014-12-10
• Last updated: 2019-09-17

Locations

4 sites across 1 country: United States