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

November 2, 2016 updated by: G & W Laboratories Inc.

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • Florida
      • Sanford, Florida, United States, 32771
        • IC Research
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Gastro Associates of Western Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  11. Clinically significant systemic disease.
  12. Pelvic radiation in the past or present.
  13. Use of any venotropic medications within 7 days from Visit 2/Day 1.
  14. Use of any anti-coagulant medications within 10 days from Visit 2/Day 1.
  15. Use of topical/anorectal corticosteroids for hemorrhoidal therapy within 7 days from Visit 2/Day 1.
  16. Use of topical/anorectal medicated hemorrhoidal therapy within 24 hours from Visit 2/Day 1.
  17. Unable to cease use of OTC or prescription medications for treatment of hemorrhoidal disease during study period.
  18. Immunocompromised subjects.
  19. Known hypersensitivity or allergies to Hydrocortisone Acetate or any component of the IP (in any dosage form).
  20. Use of any investigational drug or investigational device within 30 days prior to randomization.
  21. Previous participation in this study.
  22. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subjects ability to comply with study requirements.
  23. Subjects unable to have a spontaneous bowl movement every day prior to randomization.
  24. Rectal varicies or portal hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo suppository
Hydrogenated palm kernel oil suppositories
Hydrogenated palm kernel oil suppositories
Other Names:
  • Hydrogenated palm kernel oil suppositories
Active Comparator: Anucort-HC, 25 Mg Rectal Suppository
Hydrocortisone Acetate suppositories
Hydrocortisone acetate suppositories
Other Names:
  • Hydrocortisone acetate suppositories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding Cessation
Time Frame: Up to 18 days
The primary endpoint is bleeding cessation defined as cessation of anorectal bleeding associated with bowel movements or attempted bowel movements which does not recur after cessation for the remainder of the study period. The proportion of subjects with bleeding cessation using Anucort HCTM 25mg Rectal Suppositories will be compared statistically with the proportion of subjects using placebo.
Up to 18 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the Severity Score of Pain
Time Frame: Up To 18 days
Improvement in the Severity Score of Pain on the Visual Analogue Scale (VAS) from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
Up To 18 days
Improvement in the Severity Score of Itching
Time Frame: Up to 18 days
Improvement in the Severity Score of Itching from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
Up to 18 days
Improvement in the Severity Score of Throbbing
Time Frame: Up to 18 days
Improvement in the Severity Score of Throbbing to from baseline to Visit 3/Day 8 and Visit 4/Day 15 (End of Treatment)
Up to 18 days
Improvement in the Investigator Assessment
Time Frame: Up to 18 days
Improvement in the Investigator Assessment
Up to 18 days
Improvement in the Subject Global Assessment
Time Frame: Up to 18 days
Improvement in the Subject Global Assessment
Up to 18 days
Improvement in Severity of Bleeding
Time Frame: Up To 18 days
Improvement in the severity of Bleeding from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
Up To 18 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Allan G Coates, DO, Gastro Associates of Western Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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