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Status:

COMPLETED

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

Lead Sponsor:

G & W Laboratories Inc.

Conditions:

Internal Hemorrhoids

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 hemorrhoida...

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. Subject...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Subjects with a diagnosis of symptomatic internal hemorrhoids will be selected to participate in the study.
  • 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.
  • 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.
  • Subject may also have one or more other symptoms: pain, itching or throbbing.
  • 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
  • History of permanent full-thickness rectal prolapse.
  • Current anal fissures and/or infective anal pathology.
  • Previous history of surgery for anorectal disease (within 1 year) or any other anorectal procedures
  • Subjects who are mentally incapacitated such that informed consent cannot be obtained.
  • Clinically significant co-morbid condition.
  • Diagnosis of Inflammatory Bowel Disease (IBD).
  • Evidence or history of fecal incontinence.
  • Clinically significant Laboratory values for hematology and chemistry .
  • Subjects who have had oral, transdermal, or injectable steroid therapy within days from Visit 1/Screening.
  • 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.
  • Clinically significant systemic disease.
  • Pelvic radiation in the past or present.
  • Use of any venotropic medications within 7 days from Visit 2/Day 1.
  • Use of any anti-coagulant medications within 10 days from Visit 2/Day 1.
  • Use of topical/anorectal corticosteroids for hemorrhoidal therapy within 7 days from Visit 2/Day 1.
  • Use of topical/anorectal medicated hemorrhoidal therapy within 24 hours from Visit 2/Day 1.
  • Unable to cease use of OTC or prescription medications for treatment of hemorrhoidal disease during study period.
  • Immunocompromised subjects.
  • Known hypersensitivity or allergies to Hydrocortisone Acetate or any component of the IP (in any dosage form).
  • Use of any investigational drug or investigational device within 30 days prior to randomization.
  • Previous participation in this study.
  • Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subjects ability to comply with study requirements.
  • Subjects unable to have a spontaneous bowl movement every day prior to randomization.
  • Rectal varicies or portal hypertension.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2014

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT01913158

    Start Date

    October 1 2013

    End Date

    March 1 2014

    Last Update

    November 3 2016

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Clinical Research Associates

    Huntsville, Alabama, United States, 35801

    2

    IC Research

    Sanford, Florida, United States, 32771

    3

    Gastro Associates of Western Michigan

    Wyoming, Michigan, United States, 49519