NCT03418935

Remaxol® in Mechanical Jaundice of Non-malignant Origin

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial of Efficacy and Safety of Remaxol®, a Solution for Intravenous Infusions Produced by STPF "POLYSAN" (Russia), in Patients With Mechanical Jaundice of Non-Malignant Origin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of Remaxol (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia) infusions at dose 400 and 800 ml to treat mechanical jaundice of non-tumor cause during the first week after surgery.

Detailed description

The study will be performed in in-hospital patients with obstructive jaundice cause by conditions other than tumor (predominantly by cholelithiasis; ICD-10 codes K80 and K83.1). The patients will be screened in the 15 days preceeding the appointed drainage surgery. The treatment will be started in the first 6 hours after the drainage surgery and continue for 7 days. Following screening, patients who meet the inclusion criteria and have no criteria for exclusion will be randomly assigned into three study groups in the proportion of 1: 1: 1): Group I: treatment with Remaxol 400 ml IV + Ringer solution 400 ml IV for 7 days. Group II: treatment with Remaxol 800 ml IV for 7 days. Group III (control): Ringer solution 800 ml IV for 7 days. Physical examination data, vital signs, biochemistry panel (including bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, GGTP) will be assessed on days 1-8, on day 11 and day 14. Diagnostic abdominal ultrasound will be performed before surgery and on days 3 and 8. Neurophysiological test for the evaluation of the degree of encephalopathy will be performed before surgery, on days 3, 5, 8, and 14. All patients will be followed up for 14 days.

Conditions

• Jaundice, Obstructive

Interventions

Type	Name	Description
DRUG	Remaxol (succinate + methionine + inosine + nicotinamide)	Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
DRUG	Ringer's Solution	Intravenous infusion, 400 or 800 ml

Timeline

• Start date: 2017-04-03
• Primary completion: 2020-03-31
• Completion: 2020-04-13
• First posted: 2018-02-01
• Last updated: 2020-07-14

Locations

13 sites across 1 country: Russia