Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids
Information source: G & W Laboratories Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Internal Hemorrhoids
Intervention: Hydrocortisone acetate suppositories (Drug); Hydrogenated palm kernel oil (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: G & W Laboratories Inc. Official(s) and/or principal investigator(s): Allan G Coates, DO, Principal Investigator, Affiliation: Gastro Associates of Western Michigan
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Bleeding Cessation
Secondary outcome: Improvement in the Severity Score of PainImprovement in the Severity Score of Itching Improvement in the Severity Score of Throbbing Improvement in the Investigator Assessment Improvement in the Subject Global Assessment Improvement in Severity of Bleeding
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Clinical Research Associates, Huntsville, Alabama 35801, United States
IC Research, Sanford, Florida 32771, United States
Gastro Associates of Western Michigan, Wyoming, Michigan 49519, United States
Additional Information
Starting date: October 2013
Last updated: April 2, 2014
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