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

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

• Status: Completed
• Conditions: Internal Hemorrhoids
• Intervention / Treatment: Drug: Placebo suppository; Drug: Anucort-HC, 25 Mg Rectal Suppository

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

Study Locations

• United States
  • 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

Eligibility Criteria

• Ages Eligible for Study: 14 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Cessation	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	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	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	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	Improvement in the Investigator Assessment	Up to 18 days
Improvement in the Subject Global Assessment	Improvement in the Subject Global Assessment	Up to 18 days
Improvement in Severity of Bleeding	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

• Sponsor: G & W Laboratories Inc.
• Investigators: Principal Investigator: Allan G Coates, DO, Gastro Associates of Western Michigan

Study record dates

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

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids; Anti-Inflammatory Agents; Hydrocortisone; Hydrocortisone acetate
• Other Study ID Numbers: PRG-NY-13-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No