Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids
NCT ID: NCT01913158
Last Updated: 2016-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2013-10-31
2014-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo suppository
Hydrogenated palm kernel oil suppositories
Placebo suppository
Hydrogenated palm kernel oil suppositories
Anucort-HC, 25 Mg Rectal Suppository
Hydrocortisone Acetate suppositories
Anucort-HC, 25 Mg Rectal Suppository
Hydrocortisone acetate suppositories
Interventions
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Anucort-HC, 25 Mg Rectal Suppository
Hydrocortisone acetate suppositories
Placebo suppository
Hydrogenated palm kernel oil suppositories
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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G & W Laboratories Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Allan G Coates, DO
Role: PRINCIPAL_INVESTIGATOR
Gastro Associates of Western Michigan
Locations
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Clinical Research Associates
Huntsville, Alabama, United States
IC Research
Sanford, Florida, United States
Gastro Associates of Western Michigan
Wyoming, Michigan, United States
Countries
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Other Identifiers
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PRG-NY-13-002
Identifier Type: -
Identifier Source: org_study_id