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

NCT05157711 | Completed Phase 3

• 1 other identifier: ST-20-U92
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (14)

• Subject reported severity of heamorrhoid symptoms

  Subject will grade severity of each hemorrhoid symptom (pain, itching, swelling, bleeding, discomfort, burning, inflammation, overall Irritation, defecation discomfort/difficulty) in 10 cm VAS, from 0 (None) to 10 (Most severe).

  Day 7

• Subject reported severity of heamorrhoid symptoms

  Subject will grade severity of each hemorrhoid symptom (pain, itching, swelling, bleeding, discomfort, burning, inflammation, overall Irritation, defecation discomfort/difficulty) in 10 cm VAS, from 0 (None) to 10 (Most severe).

  Day 14

• Subject reported improvement of heamorrhoid symptoms

  Subject will grade improvement of each haemorrhoid symptom (pain, itching, swelling, bleeding, discomfort, burning, inflammation, overall Irritation, defecation discomfort/difficulty) compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete improvement).

  Day 7

• Subject reported improvement of heamorrhoid symptoms

  Subject will grade improvement of each haemorrhoid symptom (pain, itching, swelling, bleeding, discomfort, burning, inflammation, overall Irritation, defecation discomfort/difficulty) compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete improvement).

  Day 14

• Subject reported overall improvement of haemorrhoid symptoms

  Subject will rate overall improvement of haemorrhoid symptoms compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete Improvement).

  Day 7

• Subject reported overall improvement of haemorrhoid symptoms

  Subject will rate overall improvement of haemorrhoid symptoms compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete Improvement).

  Day 14

• Subject reported overall shrinkage of haemorrhoids

  Subject will rate overall shrinkage of haemorrhoids compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete Improvement).

  Day 7

• Subject reported overall shrinkage of haemorrhoids

  Subject will rate overall shrinkage of haemorrhoids compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete Improvement).

  Day 14

• Investigator reported severity of haemorrhoid symptoms and signs

  Investigator will rate each haemorrhoid symptom and sign (erythema, swelling/edema, inflammation,dryness, overall irritation, haemorrhoid severity) in six-point scale from 0 (none) to 5 (very severe).

  Day 7

• Investigator reported severity of haemorrhoid symptoms and signs

  Investigator will rate each haemorrhoid symptom and sign (erythema, swelling/edema, inflammation,dryness, overall irritation, haemorrhoid severity) in six-point scale from 0 (none) to 5 (very severe).

  Day 14

• Investigator reported overall improvement of haemorrhoid symptoms

  Investigator will rate overall improvement of haemorrhoid symptoms compared to Day 0 in six-point scale from 0 (none) to 5 (complete improvement)

  Day 7

• Investigator reported overall improvement of haemorrhoid symptoms

  Investigator will rate overall improvement of haemorrhoid symptoms compared to Day 0 in six-point scale from 0 (none) to 5 (complete improvement)

  Day 14

• Investigator reported overall shrinkage of haemorrhoids

  Investigator will rate overall shrinkage of haemorrhoids compared to Day 0 in six-point scale from 0 (none) to 5 (complete improvement).

  Day 7

• Investigator reported overall shrinkage of haemorrhoids

  Investigator will rate overall shrinkage of haemorrhoids compared to Day 0 in six-point scale from 0 (none) to 5 (complete improvement).

  Day 14

Other Outcomes (1)

• Overall product performance

  Day 14

Study Arms (3)

Anusol ointment

EXPERIMENTAL

Anusol ointment (Zinc oxide \[10.75g\], Bismuth subgallate \[2.25 g\], Balsam peru \[1.875 g\], Bismuth oxide \[0.875 g\] in each 100g of ointment).

Drug: Anusol

Benchmark

ACTIVE COMPARATOR

RELIEF® rectal ointment (phenylephrine hydrochloride 2.5mg/g), marketed

Drug: Relief [Name]

Placebo

PLACEBO COMPARATOR

Anusol ointment after the removal of the active ingredients

Drug: Placebo

Interventions

Anusol DRUG

Daily at night and in the morning and after each bowel movement for two weeks

Also known as: Anusol Ointment (Zinc oxide, Bismuth subgallate, Balsam peru), Bismuth oxide)

Anusol ointment

Relief [Name] DRUG

Daily at night and in the morning and after each bowel movement for two weeks

Also known as: RELIEF rectal ointment (phenylephrine hydrochloride)

Benchmark

Placebo DRUG

Daily at night and in the morning and after each bowel movement for two weeks

Also known as: Placebo ointment (Anusol ointment without active ingredients)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-75 years old.
• Subjects with a diagnosis of symptomatic internal and/or external haemorrhoids, confirmed by Investigator as Grade I-III.\*
• 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.
• 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.
• Non-pregnant, non-lactating female. Females should be able to distinguish rectal bleeding from menstrual vaginal bleeding.
• 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.
• 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),
• 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).
• Agrees not to participate in any clinical study from Visit 1 through end of study.
• Read, understand and sign an informed consent.
• Willing not to change their shampoo, soap or body washing products during the study.
• Willing and able to comply with study instructions.

You may not qualify if:

• 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.
• History of previous proctological surgery.
• Diagnosis of Inflammatory Bowel Disease (IBD).
• Evidence or history of fecal incontinence.
• Current diagnosis or history of an uncorrected coagulation defect or concurrently uses anticoagulants (except low dose aspirin or non-steroidals).
• Is using medication which, in the opinion of the Investigator, will interfere with the study results.
• Has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study products.
• Use of stool softeners, but not on a stable regimen during the past 28 days prior to enrolling in the study.
• Receiving treatment labeled or intended for haemorrhoids during the past 7 days prior to start of the study.
• Receiving treatment labeled or intended for haemorrhoids throughout the study, other than the assigned product.
• Use of local analgesics and/or anti-inflammatories during the past 14 days prior to the start of the study.
• Receiving Monoamine oxidase inhibitors (MAOI) within the past 14 days prior to enrolling and during the study.
• Has severe arterial hypertension, tachysystolic cardiac rhythm disturbance, decompensated heart failure, cardiac conduction disorders, severe hepatic failure, severe renal failure, thyrotoxicosis, acute pancreatitis, recurrent thromboembolism, granulocytopenia, or other clinically significant co-morbid condition, which, in PI's opinion, may affect the patient safety and/or affect participation in the study.
• Female subjects who are lactating and/or pregnant or planning to become pregnant during the study.
• Is currently participating in any clinical testing.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (2)

Erebouni Medical Center

Yerevan, Armenia

Location

Izmirlyan Medical Center

Yerevan, Armenia

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Zinc Oxide; bismuth subgallate; Peruvian balsam; bismuth oxide; Oxymetazoline; Phenylephrine

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Annahita Ghassemi, PhD

  Director, Global Product Safety & Clinical Affairs Church & Dwight Co., Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: December 15, 2021
• Study Start: November 25, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 15, 2022

Record last verified: 2021-11

Locations

AR (2)