Trial Profile

A Randomized, Dose-Ranging, Double Blind Study of Lidocaine Hydrochloride and/or Hydrocortisone Acetate (Alone or in Combination) in the 14-Day Twice-Daily Treatment of Grade I or II Hemorrhoids

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 06 Nov 2021

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At a glance

Drugs Hydrocortisone (Primary) ; Lidocaine (Primary) ; Lidocaine/hydrocortisone (Primary)
Indications Haemorrhoids
Focus Therapeutic Use
Sponsors Citius Pharmaceuticals LLC

06 Mar 2018 According to a Citius Pharmaceuticals media release, the company held a Type C meeting with the FDA to discuss the results of the Phase 2a study and to obtain the Agencys view on development plans to support the potential formulation change for the planned Phase 2b study.
04 Feb 2016 New trial record
01 Feb 2016 According to a Citius Pharmaceuticals media release, the company announced results of phase IIa trial of Hydrocortisone and Lidocaine combination cream in patients with grade I and II Hemorrhoids.

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