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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
304
Site #01
Huntsville, Alabama, United States
Site #07
Tucson, Arizona, United States
Site #06
Chula Vista, California, United States
Change in Hemorrhoid symptoms
Change in hemorrhoidal symptoms (pain, burning, itching, and swelling) as measured by the patient using a numeric rating scale.
Time frame: Day 8
Change in Hemorrhoidal bother.
Change of hemorrhoidal symptoms related to bowel movement interference and pressure as measured by the patient using a numeric rating scale.
Time frame: Day 8
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Combination cream containing Lidocaine and HBP (low)
Combination cream containing Lidocaine and HBP (high)
Site #09
Pomona, California, United States
Site #16
San Diego, California, United States
Site #03
San Diego, California, United States
Site #05
West Palm Beach, Florida, United States
Site #10
Covington, Louisiana, United States
Site #12
Prairieville, Louisiana, United States
Site #02
Wyoming, Michigan, United States
...and 6 more locations