Study of the Safety and Efficacy of Hydrocortisone Acetate Suppositories, 25 mg in the Treatment of Symptomatic Internal Hemorrhoids
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ClinicalTrials.gov Identifier: NCT03335774 |
Recruitment Status :
Completed
First Posted : November 8, 2017
Last Update Posted : April 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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Internal Hemorrhoids | Drug: Hydrocortisone Acetate Suppository, 25 mg Drug: Placebo (Vehicle) Suppository | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of Hydrocortisone Acetate Suppositories, 25 mg Compared to Placebo Suppositories in the Treatment of Symptomatic Internal Hemorrhoids |
Actual Study Start Date : | February 12, 2019 |
Actual Primary Completion Date : | March 5, 2021 |
Actual Study Completion Date : | March 5, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Hydrocortisone Acetate Suppository, 25 mg
One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
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Drug: Hydrocortisone Acetate Suppository, 25 mg
One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days). |
Placebo Comparator: Placebo (Vehicle) Suppository
One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
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Drug: Placebo (Vehicle) Suppository
One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days). |
- Change in swelling [ Time Frame: Days 1, 15 ]Anoscopy
- Change in bleeding [ Time Frame: Days 1-29 ]Questionnaire
- Change in itching [ Time Frame: Days 1-29 ]Questionnaire
- Change in swelling [ Time Frame: Days 1-29 ]Questionnaire
- Change in pain [ Time Frame: Days 1-29 ]Questionnaire
- Change in discomfort [ Time Frame: Days 1-29 ]Questionnaire
- Change in overall severity [ Time Frame: Days 1-29 ]Questionnaire

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- internal hemorrhoids.
- hemorrhoidal bleeding.
- male or female aged 18 years and older.
- willing to forego the use of non-prescription (OTC) and prescription medication or procedures for the treatment of hemorrhoidal disease and/or pain for the duration of the study.
- agree to not change their diet during the study.
Exclusion Criteria:
- external hemorrhoids.
- using other OTC or prescription medications for treatment of hemorrhoidal disease and/or pain.
- pregnant or nursing female.
- received systemic glucocorticoids within the last 2 months prior to starting study.
- participated in an investigational drug study within 30 days prior to baseline.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335774
United States, North Carolina | |
Clinical Research | |
Charlotte, North Carolina, United States, 28217 | |
India | |
Clinical Research | |
Navi Mumbai, Maharashtra, India, 400701 |
Responsible Party: | Nivagen Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT03335774 |
Other Study ID Numbers: |
HDCS 1701 (formerly 1-2017) |
First Posted: | November 8, 2017 Key Record Dates |
Last Update Posted: | April 14, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Vascular Diseases |
Cardiovascular Diseases Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Anti-Inflammatory Agents |