Overview

This trial has been completed.

Condition internal hemorrhoids
Treatments anucort-hc, 25 mg rectal suppository, placebo suppository
Phase phase 2
Sponsor G & W Laboratories Inc.
Start date October 2013
End date March 2014
Trial size 150 participants
Trial identifier NCT01913158, PRG-NY-13-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Hydrogenated palm kernel oil suppositories
placebo suppository Hydrogenated palm kernel oil suppositories
Hydrogenated palm kernel oil suppositories
(Active Comparator)
Hydrocortisone Acetate suppositories
anucort-hc, 25 mg rectal suppository Hydrocortisone acetate suppositories
Hydrocortisone acetate suppositories

Primary Outcomes

Measure
Bleeding Cessation
time frame: Up to 18 days

Secondary Outcomes

Measure
Improvement in the Severity Score of Pain
time frame: Up To 18 days
Improvement in the Severity Score of Itching
time frame: Up to 18 days
Improvement in the Severity Score of Throbbing
time frame: Up to 18 days
Improvement in the Investigator Assessment
time frame: Up to 18 days
Improvement in the Subject Global Assessment
time frame: Up to 18 days
Improvement in Severity of Bleeding
time frame: Up To 18 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Allan G Coates, DO
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by G & W Laboratories Inc..