NCT05157711

Clinical Trial of Anusol Ointment for Symptom Relief in Patients With Haemorrhoids

A Randomized, Placebo- and Benchmark-controlled, Double-blind Clinical Trial of Anusol Topical Ointment to Evaluate Symptom Relief in Patients With Haemorrhoids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Anusol topical ointment for the relief of internal and external haemorrhoid symptoms in people with Grades I-III haemorrhoids compared to a placebo (the study medication without the active ingredients) and a benchmark product.

Detailed description

Adult patients with haemorrhoids meeting all the eligibility criteria will be allocated in three study arms: test, placebo and benchmark. Approximately twenty-two subjects per group will be enrolled to assure that approximately 20 subjects in each group complete the study. The study will be conducted in Armenia.The study will last approximately 2 weeks for each subject and will consist of 3 visits. The first subject first visit is planned for June 2021, and the study will continue until the target sample size is reached.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DRUG	Anusol	Daily at night and in the morning and after each bowel movement for two weeks
DRUG	Relief [Name]	Daily at night and in the morning and after each bowel movement for two weeks
DRUG	Placebo	Daily at night and in the morning and after each bowel movement for two weeks

Timeline

• Start date: 2021-11-25
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-12-15
• Last updated: 2022-08-15

Locations

2 sites across 1 country: Armenia