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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
G & W Laboratories Inc.
ClinicalTrials.gov Identifier:
NCT01913158
First received: May 24, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Internal Hemorrhoids
Drug: Hydrocortisone acetate suppositories
Drug: Hydrogenated palm kernel oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by G & W Laboratories Inc.:

Primary Outcome Measures:
  • Bleeding Cessation [ Time Frame: Up to 18 days ] [ Designated as safety issue: Yes ]
    The primary endpoint is bleeding cessation defined as cessation of anorectal bleeding associated with bowel movements or attempted bowel movements which does not recur after cessation for the remainder of the study period. The proportion of subjects with bleeding cessation using Anucort HCTM 25mg Rectal Suppositories will be compared statistically with the proportion of subjects using placebo.


Secondary Outcome Measures:
  • Improvement in the Severity Score of Pain [ Time Frame: Up To 18 days ] [ Designated as safety issue: Yes ]
    Improvement in the Severity Score of Pain on the Visual Analogue Scale (VAS) from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)

  • Improvement in the Severity Score of Itching [ Time Frame: Up to 18 days ] [ Designated as safety issue: Yes ]
    Improvement in the Severity Score of Itching from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)

  • Improvement in the Severity Score of Throbbing [ Time Frame: Up to 18 days ] [ Designated as safety issue: Yes ]
    Improvement in the Severity Score of Throbbing to from baseline to Visit 3/Day 8 and Visit 4/Day 15 (End of Treatment)

  • Improvement in the Investigator Assessment [ Time Frame: Up to 18 days ] [ Designated as safety issue: Yes ]
    Improvement in the Investigator Assessment

  • Improvement in the Subject Global Assessment [ Time Frame: Up to 18 days ] [ Designated as safety issue: Yes ]
    Improvement in the Subject Global Assessment

  • Improvement in Severity of Bleeding [ Time Frame: Up To 18 days ] [ Designated as safety issue: Yes ]
    Improvement in the severity of Bleeding from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)


Estimated Enrollment: 150
Study Start Date: October 2013
Estimated Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Hydrogenated palm kernel oil
Hydrogenated palm kernel oil
Drug: Hydrogenated palm kernel oil
Hydrogenated palm kernel oil suppositories
Active Comparator: Hydrocortisone Acetate suppositories
Hydrocortisone Acetate suppositories
Drug: Hydrocortisone acetate suppositories
Hydrocortisone acetate suppositories

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913158

Locations
United States, Alabama
Clinical Research Associates
Huntsville, Alabama, United States, 35801
United States, Florida
IC Research
Sanford, Florida, United States, 32771
United States, Michigan
Gastro Associates of Western Michigan
Wyoming, Michigan, United States, 49519
Sponsors and Collaborators
G & W Laboratories Inc.
Investigators
Principal Investigator: Allan G Coates, DO Gastro Associates of Western Michigan
  More Information

No publications provided

Responsible Party: G & W Laboratories Inc.
ClinicalTrials.gov Identifier: NCT01913158     History of Changes
Other Study ID Numbers: PRG-NY-13-002
Study First Received: May 24, 2013
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on July 26, 2014