Hemorrhoidal DiseasePhase 2NCT07909291
A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Evaluate the Safety and Efficacy of Two Dosage Regimens of a Novel Hydrocortisone Acetate Suppository Formulation Administered With a Proprietary Suppository Applicator in Subjects With Hemorrhoidal Disease
A Phase 2 study testing hydrocortisone acetate 50 mg, hydrocortisone acetate 75 mg and proprietary suppository applicator in people with Hemorrhoidal Disease, run by Cristcot LLC.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of two dosage regimens of hydrocortisone acetate suppository administered with a proprietary suppository applicator (Study Drug) compared to placebo in the treatment of hemorrhoidal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoidal Disease
- What is being tested?
- hydrocortisone acetate 50 mg, hydrocortisone acetate 75 mg and proprietary suppository applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or nonpregnant, nonlactating females aged 18 years or older.
- Willing to abstain from other treatments for hemorrhoidal disease throughout the study, including nonprescription medications, prescription medications, and procedures. Stable-dose fiber supplements are permitted.
- Females of childbearing potential must meet the protocol-defined contraception requirements. The protocol defines childbearing potential as having a uterus and at least one ovary and not being postmenopausal. Postmenopause is defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum FSH greater than 40 mIU/mL. The protocol lists the following acceptable methods or conditions: surgical sterility by bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening; an intrauterine device in place at least 1 month before screening; barrier contraception (condom or diaphragm) with spermicide, or male-partner condom use, for at least 1 month before Day 1 and continuing throughout the study and for at least 3 days after the last dose; hormonal contraception for at least 6 weeks before Day 1 and continuing throughout the study and for at least 3 days after the last dose; or continuous abstinence from penile-vaginal intercourse for at least 1 month before Day 1 and throughout the study and for 3 days after the last dose.
- External anal skin tags are permitted. These are healed, asymptomatic tissue remnants from previously bulging internal hemorrhoids and do not preclude concomitant active hemorrhoids.
- Grade 2-3 internal hemorrhoids assessed by the Investigator using digital rectal examination and anoscopy at Day 1. Externally prolapsing internal hemorrhoids that can be manually reduced during digital rectal examination are permitted.
- At Day 1, at least two hemorrhoid-related rectal or anal symptoms of pain, burning, itching, bleeding, anal leakage, or discomfort rated "Moderate" or "Somewhat" or higher on HDSIM questions 1-8.
Who cannot join
- External hemorrhoids, described in the protocol as external to the dentate line, or Grade 4 internal hemorrhoids that cannot be manually reduced during digital rectal examination.
- Current anal fissures.
- Any hemorrhoidal procedure, such as anorectal surgery, hemorrhoidal ligation, or hemorrhoidectomy.
- Diagnosis of inflammatory bowel disease.
- Systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher. Participants receiving treatment for hypertension may participate if both readings are below these thresholds.
- Diagnosed fecal incontinence within the preceding 6 months. Fecal incontinence is distinguished from hemorrhoid-related anal leakage.
Show all 19Show fewer
- Grade 3 or Grade 4 laboratory abnormalities according to the FDA's 2007 toxicity grading guidance for preventive vaccine trials; clinically significant Grade 1 or Grade 2 laboratory abnormalities as determined by the Investigator; or an ACTH stimulation test result outside the normal range as determined by the Supervising Endocrinologist. Examples of clinically significant conditions include uncontrolled type 1 or type 2 diabetes, uncontrolled abnormal thyroid function, impaired liver function, sclerosing cholangitis, cirrhosis or hepatic impairment, significant renal disease, thrombocytopenia, neutropenia, or active systemic infection.
- A positive serology test result at screening.
- Vaccination within 2 weeks before signing informed consent or during the study, and/or surgical or other procedures that increase exposure to pathogens.
- Systemic symptoms, melena, or a clinical presentation suggesting underlying pathology requiring diagnostic evaluation rather than symptomatic hemorrhoid treatment.
- Any active infection.
- Steroid therapy within 28 days before screening or required during the study.
- History of fissure, fistula-in-ano, abscess, arteriovenous malformations, proctalgia fugax, rectal cancer, or another pathological condition of the anus or rectum other than symptomatic internal hemorrhoids.
- Past or current pelvic radiation.
- Known hypersensitivity or allergy to hydrocortisone acetate, hydrocortisone, or any suppository component.
- Participation in another investigational clinical study within 30 days before screening or during this study.
- Previous randomization in this study. A participant may be rescreened once with Medical Monitor approval.
- Any clinically significant finding or comorbid condition, including drug or alcohol abuse, that would jeopardize participant health or safety, as determined by the Investigator.
- Use of prohibited medications without completing the protocol-required washout period.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to evaluate the efficacy of two dosage regimens of hydrocortisone acetate suppository administered with a proprietary suppository applicator (Study Drug) compared to placebo in the treatment of hemorrhoidal disease.
The primary objective is to assess HDSIM symptom improvement (worst degree) characterized by the improvement in the sum of the 8 symptom components after 2 weeks of study therapy.
Read more
The secondary objective is to individually assess the HDSIM summary categories (bowel health, life impact, mental health impact, manage-ability) characterized by relative percent difference after 2 weeks of study therapy versus placebo control.
Participants will self-administer the study drug with a proprietary suppository applicator twice daily for 14 days. Participants will use an electronic/paper diary to report and capture responses to the Full HDSIM.
Read the detailed description
See above description
- Conditions
- Hemorrhoidal Disease
- Being tested
- hydrocortisone acetate 50 mg, hydrocortisone acetate 75 mg, Placebo, proprietary suppository applicator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisone acetate 50 mgDrug
50 mg hydrocortisone acetate rectal suppository
hydrocortisone acetate 75 mgDrug
75 mg hydrocortisone acetate rectal suppository
PlaceboDrug
placebo rectal suppository
proprietary suppository applicatorDevice
proprietary rectal suppository applicator
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BID Active, 50 mg | Active comparator | Twice Daily (morning and evening) administration of study drug at 50 mg, using proprietary suppository applicator. Receives: Drug: hydrocortisone acetate 50 mg; Device: proprietary suppository applicator |
| Arm B: BID, Active 75 mg | Active comparator | Twice Daily (morning and evening) administration of study drug at 75 mg, using proprietary suppository applicator. Receives: Drug: hydrocortisone acetate 75 mg; Device: proprietary suppository applicator |
| Arm C: BID, Placebo | Placebo comparator | Twice daily (morning and evening) administration of placebo, using proprietary suppository applicator. Receives: Drug: Placebo; Device: proprietary suppository applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of 50 mg and 75 mg hydrocortisone acetate suppositories compared to placebo, in the treatment of hemorrhoidal disease, using HDSIM patient reported outcome instrument
To evaluate the efficacy of two dosage regimens of hydrocortisone acetate suppository administered with a proprietary suppository applicator (Study Drug) compared to placebo in the treatment of hemorrhoidal disease (HD) at Week 2 (Day 15) versus Baseline (Day 1). The evaluation uses the Hemorrohoid Disease Symptom \& Impact Measure (HDSIM™, Appendix A), a Patient-reported Outcome (PRO) instrument developed for this purpose, and is based on the difference in the sum of the HD Symptoms Score (HDSIM questions 1through 8 which measures symptoms at their worst) for each of the two dosage regimens of the Study Drug compared to placebo at the End of Treatment (Day 15) versus Baseline (Day 1) divided by the sum of the Baseline (Day 1) component scores.
Measured: 15 days
Secondary outcomes (1)
Change From Baseline to Day 15 in Hemorrhoid Disease Symptom & Impact Measure (HDSIM) Component Scores
The Hemorrhoid Disease Symptom \& Impact Measure (HDSIM) is a participant-reported questionnaire assessing the preceding 24 hours. Mean changes from Baseline (Day 1) to End of Treatment (Day 15) are assessed separately for bowel health, life impact, mental health impact, and manageability, comparing each active treatment regimen with placebo. Items have five ordered response options, ranging from "Never" to "Always" or "Not at all" to "Very much." Responses toward "Always" or "Very much" indicate greater burden for bowel health, life impact, and mental health impact. For manageability, responses toward "Very much" indicate better coping, greater manageability, or greater confidence in treatment effectiveness.
Measured: Baseline (Day 1) and End of Treatment (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoidal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristcot LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909291
- Sponsor's protocol ID
- CHD2526
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Evaluate the Safety and Efficacy of Two Dosage Regimens of a Novel Hydrocortisone Acetate Suppository Formulation Administered With a Proprietary Suppository Applicator in Subjects With Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT07909291
- Acronym / sponsor ID
- CHD2526
- Conditions
- Hemorrhoidal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cristcot LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Nov 2026 (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 goal of this clinical trial is to evaluate the efficacy of two dosage regimens of hydrocortisone acetate suppository administered with a proprietary suppository applicator (Study Drug) compared to placebo in the treatment of hemorrhoidal disease.
The primary objective is to assess HDSIM symptom improvement (worst degree) characterized by the improvement in the sum of the 8 symptom components after 2 weeks of study therapy.
The secondary objective is to individually assess the HDSIM summary categories (bowel health, life impact, mental health impact, manage-ability) characterized by relative percent difference after 2 weeks of study therapy versus placebo control.
Participants will self-administer the study drug with a proprietary suppository applicator twice daily for 14 days. Participants will use an electronic/paper diary to report and capture responses to the Full HDSIM.
Detailed description
See above description
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: BID Active, 50 mg | Active comparator | Drug: hydrocortisone acetate 50 mg, Device: proprietary suppository applicatorTwice Daily (morning and evening) administration of study drug at 50 mg, using proprietary suppository applicator. |
| Arm B: BID, Active 75 mg | Active comparator | Drug: hydrocortisone acetate 75 mg, Device: proprietary suppository applicatorTwice Daily (morning and evening) administration of study drug at 75 mg, using proprietary suppository applicator. |
| Arm C: BID, Placebo | Placebo comparator | Drug: Placebo, Device: proprietary suppository applicatorTwice daily (morning and evening) administration of placebo, using proprietary suppository applicator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult males or nonpregnant, nonlactating females aged 18 years or older.
- Willing to abstain from other treatments for hemorrhoidal disease throughout the study, including nonprescription medications, prescription medications, and procedures. Stable-dose fiber supplements are permitted.
- Females of childbearing potential must meet the protocol-defined contraception requirements. The protocol defines childbearing potential as having a uterus and at least one ovary and not being postmenopausal. Postmenopause is defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum FSH greater than 40 mIU/mL. The protocol lists the following acceptable methods or conditions: surgical sterility by bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening; an intrauterine device in place at least 1 month before screening; barrier contraception (condom or diaphragm) with spermicide, or male-partner condom use, for at least 1 month before Day 1 and continuing throughout the study and for at least 3 days after the last dose; hormonal contraception for at least 6 weeks before Day 1 and continuing throughout the study and for at least 3 days after the last dose; or continuous abstinence from penile-vaginal intercourse for at least 1 month before Day 1 and throughout the study and for 3 days after the last dose.
- External anal skin tags are permitted. These are healed, asymptomatic tissue remnants from previously bulging internal hemorrhoids and do not preclude concomitant active hemorrhoids.
- Grade 2-3 internal hemorrhoids assessed by the Investigator using digital rectal examination and anoscopy at Day 1. Externally prolapsing internal hemorrhoids that can be manually reduced during digital rectal examination are permitted.
Key exclusion criteria (19 listed)
- External hemorrhoids, described in the protocol as external to the dentate line, or Grade 4 internal hemorrhoids that cannot be manually reduced during digital rectal examination.
- Current anal fissures.
- Any hemorrhoidal procedure, such as anorectal surgery, hemorrhoidal ligation, or hemorrhoidectomy.
- Diagnosis of inflammatory bowel disease.
- Systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher. Participants receiving treatment for hypertension may participate if both readings are below these thresholds.
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 |
|---|---|---|
| hydrocortisone acetate 50 mg50 mg hydrocortisone acetate rectal suppository | Drug | Arm A: BID Active, 50 mg |
| hydrocortisone acetate 75 mg75 mg hydrocortisone acetate rectal suppository | Drug | Arm B: BID, Active 75 mg |
| Placeboplacebo rectal suppository | Drug | Arm C: BID, Placebo |
| proprietary suppository applicatorproprietary rectal suppository applicator | Device | Arm A: BID Active, 50 mg, Arm B: BID, Active 75 mg, Arm C: BID, Placebo |
Primary outcome
Efficacy of 50 mg and 75 mg hydrocortisone acetate suppositories compared to placebo, in the treatment of hemorrhoidal disease, using HDSIM patient reported outcome instrument
Time frame: 15 days
To evaluate the efficacy of two dosage regimens of hydrocortisone acetate suppository administered with a proprietary suppository applicator (Study Drug) compared to placebo in the treatment of hemorrhoidal disease (HD) at Week 2 (Day 15) versus Baseline (Day 1). The evaluation uses the Hemorrohoid Disease Symptom \& Impact Measure (HDSIM™, Appendix A), a Patient-reported Outcome (PRO) instrument developed for this purpose, and is based on the difference in the sum of the HD Symptoms Score (HDSIM questions 1through 8 which measures symptoms at their worst) for each of the two dosage regimens of the Study Drug compared to placebo at the End of Treatment (Day 15) versus Baseline (Day 1) divided by the sum of the Baseline (Day 1) component scores.
1 secondary outcome
Change From Baseline to Day 15 in Hemorrhoid Disease Symptom & Impact Measure (HDSIM) Component Scores
Time frame: Baseline (Day 1) and End of Treatment (Day 15)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydrocortisone acetate 50 mg, hydrocortisone acetate 75 mg and proprietary suppository applicator in people with Hemorrhoidal Disease, run by Cristcot LLC.
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 6 inclusion and 19 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Gonzalez (737-212-9117, monica.gonzalez@cristcot.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of 50 mg and 75 mg hydrocortisone acetate suppositories compared to placebo, in the treatment of hemorrhoidal disease, using HDSIM patient reported outcome instrument (time frame: 15 days). 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 2 Nov 2026.