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Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids

Hemorrhoids Clinical Trial

Official title:
A Randomized, Dose-Ranging, Double Blind Study to Demonstrate the Safety and Efficacy of a CITI-002 Cream in the Seven Day Twice-Daily Treatment of Grade II or III Hemorrhoids

Clinical Trial Summary

A Randomized Phase 2 double blind study which aims to determine the safety and efficacy of CITI-002 cream in adult patients with Goligher's grade II or III hemorrhoids.

Clinical Trial Description

This Phase 2 study aims to compare the safety and efficacy of 5 different treatment groups. The study drug will be applied twice daily for 7 days. Response to the study drug will be measured through patient responses to an electronic Patient Reported Outcome (ePRO). There are 4 study visits: first visit is screening (day 1), follow-up visit (day 5), end of treatment (day 8), and end of study visit (day 15). There will also be one telephone visit on day 2. This study will be done in ~16 US sites and about 300 subjects will be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05348200
Study type Interventional
Source Citius Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date April 22, 2022
Completion date May 17, 2023
View Details
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