NCT05348200

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Citius Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DRUG	Monad 1	Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic.
DRUG	Monad 2	Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid.
DRUG	Monad 3	Single therapy cream containing Halobetasol Propionate (high strength).
DRUG	Combination - CITI-002 (low dose)	Combination cream containing Lidocaine and HBP (low)
DRUG	Combination - CITI-002 (high dose)	Combination cream containing Lidocaine and HBP (high)

Timeline

• Start date: 2022-04-22
• Primary completion: 2023-04-20
• Completion: 2023-05-17
• First posted: 2022-04-27
• Last updated: 2023-08-31

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study