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COMPLETEDPHASE3

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

NCT05157711•Church & Dwight Company, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, 18-75 years old.
•2. Subjects with a diagnosis of symptomatic internal and/or external haemorrhoids, confirmed by Investigator as Grade I-III.\*
•3. Has at least two of the following haemorrhoid symptoms for at least two consecutive days immediately prior to screening: pain, discomfort, itching, irritation, burning, inflammation, swelling, bleeding, or defecation discomfort/difficulty.
•4. Has at least two of the following haemorrhoid symptoms with at least moderate intensity (\>4 reported by subject) at the baseline/screening: pain, discomfort, itching, irritation, burning, inflammation, swelling, bleeding or defecation discomfort/difficulty.
•5. Non-pregnant, non-lactating female. Females should be able to distinguish rectal bleeding from menstrual vaginal bleeding.
•6. In the case of a female of childbearing potential (CBP), using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device (IUD), condom with spermicide, diaphragm with spermicide, partner's vasectomy, bilateral tubal ligation). Abstinence or vasectomies are acceptable, but if the female subject's lifestyle or partner changes then she will agree to implement one of the other acceptable methods of birth control.
•7. In the case of a female of child-bearing potential, has a negative urine pregnancy dipstick test (UPT) at Visit 1 prior to randomization and are willing to submit to a UPT at Visit 2 and at the end of study (EOS),
•8. In the case of a female of non-childbearing potential, has had a hysterectomy or is postmenopausal (at least 1 year with no menses prior to enrollment).
•9. Agrees not to participate in any clinical study from Visit 1 through end of study.
•10. Read, understand and sign an informed consent.
+2 more criteria

Exclusion Criteria

•1. Has anorectal condition(s) such as malignant tumors of the anus or rectum, fistula-in-ano or chronic sepsis, fissure-in-ano, incontinence, condylomata and Grade IV haemorrhoids.
•2. History of previous proctological surgery.
•3. Diagnosis of Inflammatory Bowel Disease (IBD).
•4. Evidence or history of fecal incontinence.
•5. Current diagnosis or history of an uncorrected coagulation defect or concurrently uses anticoagulants (except low dose aspirin or non-steroidals).
•6. Is using medication which, in the opinion of the Investigator, will interfere with the study results.
•7. Has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study products.
•8. Use of stool softeners, but not on a stable regimen during the past 28 days prior to enrolling in the study.
•9. Receiving treatment labeled or intended for haemorrhoids during the past 7 days prior to start of the study.
•10. Receiving treatment labeled or intended for haemorrhoids throughout the study, other than the assigned product.
+6 more criteria

Locations (2)

Erebouni Medical Center

Yerevan, Armenia

Izmirlyan Medical Center

Yerevan, Armenia

Key Dates

Start Date

November 25, 2021

Primary Completion Date

March 31, 2022

Completion Date

March 31, 2022

Last Updated

August 15, 2022

Enrollment

ACTUAL participants

Conditions

Hemorrhoids

Interventions

Anusol

DRUG

Relief [Name]

DRUG

Placebo

DRUG

Ketamine for Post-operative Analgesia in Hemorrhoidectomy

NCT04248205

Hemorrhoids

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RECRUITING

Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease

NCT03972956

Colorectal CancerGastric Cancer+4 more

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ENROLLING_BY_INVITATION

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Ketamine for Post-operative Analgesia in Hemorrhoidectomy

Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease

The Effect of Methylene Blue Infiltrating Injection on Anal Pain After Milligan-Morgan Surgery: a Randomized Controlled Clinical Study

Evaluation of the Value of Perianal Infiltration During Thermodestruction of Haemorrhoidal Disease by Radiofrequency

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Minimally Invasive Open Excisional Hemorrhoidectomy Compared to Conventional Open Excisional Hemorrhoidectomy: a Clinical Trial