HemorrhoidsPhase 3NCT05157711
Clinical Trial of Anusol Ointment for Symptom Relief in Patients With Haemorrhoids
A Phase 3 study testing Anusol and Relief [Name] in people with Hemorrhoids, run by Church & Dwight Company, Inc. at 2 sites in Armenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Anusol and Relief [Name]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesArmenia
- Study dates
- 25 Nov 2021to 31 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Has received any investigational drug(s) within 28 days before start of the study.
Trial locations and contacts
2 sites in 1 country.
Armenia2 sites
Erebouni Medical Center
Yerevan
Izmirlyan Medical Center
Yerevan
About this study
Official title: A Randomized, Placebo- and Benchmark-controlled, Double-blind Clinical Trial of Anusol Topical Ointment to Evaluate Symptom Relief in Patients With Haemorrhoids
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.
Read the 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
- Being tested
- Anusol, Relief [Name], Placebo
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnusolDrug
Also called Anusol Ointment (Zinc oxide, Bismuth subgallate, Balsam peru), Bismuth oxide)
Daily at night and in the morning and after each bowel movement for two weeks
Relief [Name]Drug
Also called RELIEF rectal ointment (phenylephrine hydrochloride)
Daily at night and in the morning and after each bowel movement for two weeks
PlaceboDrug
Also called Placebo ointment (Anusol ointment without active ingredients)
Daily at night and in the morning and after each bowel movement for two weeks
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Anusol |
| Benchmark | Active comparator | RELIEF® rectal ointment (phenylephrine hydrochloride 2.5mg/g), marketed Receives: Drug: Relief [Name] |
| Placebo | Placebo comparator | Anusol ointment after the removal of the active ingredients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start25 Nov 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annahita Ghassemi, PhD, Study director, Director, Global Product Safety & Clinical Affairs Church & Dwight Co., Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157711
- Sponsor's protocol ID
- ST-20-U92
- Status last verified
- Nov 2021
- First submitted
- 10 May 2021
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo- and Benchmark-controlled, Double-blind Clinical Trial of Anusol Topical Ointment to Evaluate Symptom Relief in Patients With Haemorrhoids
- ClinicalTrials.gov ID
- NCT05157711
- Acronym / sponsor ID
- ST-20-U92
- Conditions
- Hemorrhoids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anusol ointment | Experimental | Drug: AnusolAnusol 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). |
| Benchmark | Active comparator | Drug: Relief [Name]RELIEF® rectal ointment (phenylephrine hydrochloride 2.5mg/g), marketed |
| Placebo | Placebo comparator | Drug: PlaceboAnusol ointment after the removal of the active ingredients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnusolAlso: Anusol Ointment (Zinc oxide, Bismuth subgallate, Balsam peru), Bismuth oxide)Daily at night and in the morning and after each bowel movement for two weeks | Drug | Anusol ointment |
| Relief [Name]Also: RELIEF rectal ointment (phenylephrine hydrochloride)Daily at night and in the morning and after each bowel movement for two weeks | Drug | Benchmark |
| PlaceboAlso: Placebo ointment (Anusol ointment without active ingredients)Daily at night and in the morning and after each bowel movement for two weeks | Drug | Placebo |
Primary outcome
Subject reported severity of heamorrhoid symptoms
Time frame: Day 7
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).
Subject reported severity of heamorrhoid symptoms
Time frame: Day 14
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).
Subject reported improvement of heamorrhoid symptoms
Time frame: Day 7
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).
Subject reported improvement of heamorrhoid symptoms
Time frame: Day 14
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).
Subject reported overall improvement of haemorrhoid symptoms
Time frame: Day 7
Subject will rate overall improvement of haemorrhoid symptoms compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete Improvement).
Subject reported overall improvement of haemorrhoid symptoms
Time frame: Day 14
Subject will rate overall improvement of haemorrhoid symptoms compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete Improvement).
Subject reported overall shrinkage of haemorrhoids
Time frame: Day 7
Subject will rate overall shrinkage of haemorrhoids compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete Improvement).
Subject reported overall shrinkage of haemorrhoids
Time frame: Day 14
Subject will rate overall shrinkage of haemorrhoids compared to Day 0 in 10 cm VAS from 0 (None) to 10 (Complete Improvement).
Investigator reported severity of haemorrhoid symptoms and signs
Time frame: Day 7
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).
Investigator reported severity of haemorrhoid symptoms and signs
Time frame: Day 14
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).
Investigator reported overall improvement of haemorrhoid symptoms
Time frame: Day 7
Investigator will rate overall improvement of haemorrhoid symptoms compared to Day 0 in six-point scale from 0 (none) to 5 (complete improvement)
Investigator reported overall improvement of haemorrhoid symptoms
Time frame: Day 14
Investigator will rate overall improvement of haemorrhoid symptoms compared to Day 0 in six-point scale from 0 (none) to 5 (complete improvement)
Investigator reported overall shrinkage of haemorrhoids
Time frame: Day 7
Investigator will rate overall shrinkage of haemorrhoids compared to Day 0 in six-point scale from 0 (none) to 5 (complete improvement).
Investigator reported overall shrinkage of haemorrhoids
Time frame: Day 14
Investigator will rate overall shrinkage of haemorrhoids compared to Day 0 in six-point scale from 0 (none) to 5 (complete improvement).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annahita Ghassemi, PhD study director
Director, Global Product Safety & Clinical Affairs Church & Dwight Co., Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anusol and Relief [Name] in people with Hemorrhoids, run by Church & Dwight Company, Inc. at 2 sites in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject reported severity of heamorrhoid symptoms (time frame: Day 7). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.