Clinical trial NCT01913158: Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Internal Hemorrhoids
Lead sponsor: G & W Laboratories Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Bleeding Cessation
timeFrame: Up to 18 days
Secondary outcomes:
measure: Improvement in the Severity Score of Pain
timeFrame: Up To 18 days
measure: Improvement in the Severity Score of Itching
timeFrame: Up to 18 days
measure: Improvement in the Severity Score of Throbbing
timeFrame: Up to 18 days
measure: Improvement in the Investigator Assessment
timeFrame: Up to 18 days
measure: Improvement in the Subject Global Assessment
timeFrame: Up to 18 days
measure: Improvement in Severity of Bleeding
timeFrame: Up To 18 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Sanford
country: United States
facility: IC Research
state: Florida
city: Wyoming
country: United States
facility: Gastro Associates of Western Michigan
state: Michigan
Study officials:
affiliation: Gastro Associates of Western Michigan
name: Allan G Coates, DO
role: PRINCIPAL_INVESTIGATOR
References: