NCT03660787

Efficacy and Dose Ranging Study of Seroguard

Phase II Multi-center Randomized Double-blind Placebo-controlled Efficacy and Dose Ranging Trial of the Drug Product Seroguard, Solution (JSC Pharmasyntez, Russia) Used for the Prevention of Pelvic Adhesions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Pharmasyntez · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled, phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic adhesive disease in Study centres in Russia.

Detailed description

In order to evaluate efficacy and safety of Seroguard, solution for IP administration, a study design meeting the set objectives was selected: prospective, multi-center, double-blind, randomized, parallel group, placebo-controlled study. Given the fact that comparison with placebo is considered the best way to prove efficacy and safety of a drug and that currently there are no drugs with a similar mechanism of action at the pharmaceutical product market, a placebo-controlled, parallel group study design was selected. A randomized, parallel group study design was chosen in order to ensure minimization of a selection bias. Subjects were randomized into four groups (two groups of the test drug and two placebo groups corresponding to the two doses) to enable a comparison of Seroguard administration at two doses. A double-blind study design was selected in order to ensure minimization of an outcome evaluation bias.

Conditions

• Adhesion

Interventions

Type	Name	Description
DRUG	Seroguard	Seroguard 0.41 g/L solution
DRUG	Placebo	Saline

Timeline

• Start date: 2017-05-04
• Primary completion: 2018-01-23
• Completion: 2018-01-23
• First posted: 2018-09-07
• Last updated: 2019-06-19
• Results posted: 2019-06-19

Locations

14 sites across 1 country: Russia