NCT05586789

A Study of the Efficacy and Safety of Ranquilon Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

A Double-blind, Randomized, Placebo-controlled, Multicenter Phase III Clinical Trial to Examine the Clinical Efficacy and Safety of Ranquilon, 1 mg Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in neurasthenia and adjustment disorder. An additional study objective was to evaluate the safety of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo in patients with anxiety in neurasthenia and adjustment disorder.

Conditions

• Anxiety
• Neurasthenia
• Adjustment Disorders

Interventions

Type	Name	Description
DRUG	Ranquilon	Two 1 mg tablets 3 times per day for 28 days
DRUG	Placebo	Two tablets 3 times per day for 28 days

Timeline

• Start date: 2022-10-12
• Primary completion: 2022-11-22
• Completion: 2023-01-03
• First posted: 2022-10-19
• Last updated: 2023-07-27

Locations

10 sites across 1 country: Russia