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Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids | Clinical Trials | Clareo Health

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Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate Safety and Efficacy of Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in the Treatment of Symptomatic Internal Hemorrhoids

NCT01913158•G & W Laboratories Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine the safety and efficacy of G\&W Laboratories' Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects with internal hemorrhoidal symptoms.

Detailed Description

This is a randomized, vehicle-controlled, multicenter, double blind study of Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects with symptomatic internal hemorrhoids. Subjects will be randomly assigned in a 1:1 ratio to Test product or Vehicle, respectively. Clinical evaluations will be performed at: Visit 1/Day -3 (-1 day) to Day 1 Screening Visit 2/Day 1 Randomization (Start of Treatment) Visit 3/Day 8 (-1/+3 days) Interim Visit 4/Day 15 (-1/+3 days) End of Treatment / Early Termination Visit 5/ Day 28 (-1/+3 days)\* 2 Weeks Post-Treatment/Follow-Up Phone Contact Safety will be assessed by monitoring adverse events (AEs) and clinically significant changes from Visit 1/Screening in laboratory values. Number of Sites: Approximately 31 sites in the United States.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects with a diagnosis of symptomatic internal hemorrhoids will be selected to participate in the study.
•2. Eligible subjects will be males or non-pregnant, non-lactating, non-menstruating females; ≥ 18 years of age; with diagnosis of Grade I, II or III internal hemorrhoidal disease.
•3. For study entry the subject must have had anorectal bleeding during or after at least 2 of the 4 most recent attempted or successful bowel movements prior to Screening.
•4. Subject may also have one or more other symptoms: pain, itching or throbbing.
•5. At Visit 2/Day 1 (Randomization) subject must have recorded at least 2 instances of anorectal bleeding and no more than 1 incidence of no anorectal bleeding during attempted or successful bowel movements during the screening period between Visit 1/ Day -3 (Screening) and prior to Visit 2/Day 1 (Randomization).

Exclusion Criteria

•1. History of permanent full-thickness rectal prolapse.
•2. Current anal fissures and/or infective anal pathology.
•3. Previous history of surgery for anorectal disease (within 1 year) or any other anorectal procedures
•4. Subjects who are mentally incapacitated such that informed consent cannot be obtained.
•5. Clinically significant co-morbid condition.
•6. Diagnosis of Inflammatory Bowel Disease (IBD).
•7. Evidence or history of fecal incontinence.
•8. Clinically significant Laboratory values for hematology and chemistry .
•9. Subjects who have had oral, transdermal, or injectable steroid therapy within days from Visit 1/Screening.
•10. Presence of fissure or a fistula-in-ano, abscess, severe diverticular disease, polyps or colorectal adenoma or colorectal cancer, arteriovenous malformations, or any other pathological condition of the anus, colon or rectum other than symptomatic internal hemorrhoids which might be a potential cause of hematochezia.
+14 more criteria

Locations (3)

Clinical Research Associates

Huntsville, Alabama, United States

IC Research

Sanford, Florida, United States

Gastro Associates of Western Michigan

Wyoming, Michigan, United States

Key Dates

Start Date

October 1, 2013

Primary Completion Date

March 1, 2014

Completion Date

March 1, 2014

Last Updated

November 3, 2016

Enrollment

150

ACTUAL participants

Conditions

Internal Hemorrhoids

Interventions

Anucort-HC, 25 Mg Rectal Suppository

DRUG

Placebo suppository

DRUG

HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids

NCT07333040

Hemorrhoids Third DegreeInternal Hemorrhoids+1 more

View study

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: November 3, 2016Data 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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