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

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.