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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01913158
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
G & W Laboratories Inc.

Tracking Information
First Submitted Date  ICMJE May 24, 2013
First Posted Date  ICMJE July 31, 2013
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2013)
Bleeding Cessation [ Time Frame: Up to 18 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01913158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2013)
  • Improvement in the Severity Score of Pain [ Time Frame: Up To 18 days ]
    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 ]
    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 ]
    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 ]
    Improvement in the Investigator Assessment
  • Improvement in the Subject Global Assessment [ Time Frame: Up to 18 days ]
    Improvement in the Subject Global Assessment
  • Improvement in Severity of Bleeding [ Time Frame: Up To 18 days ]
    Improvement in the severity of Bleeding from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Internal Hemorrhoids
Intervention  ICMJE
  • Drug: Anucort-HC, 25 Mg Rectal Suppository
    Hydrocortisone acetate suppositories
    Other Name: Hydrocortisone acetate suppositories
  • Drug: Placebo suppository
    Hydrogenated palm kernel oil suppositories
    Other Name: Hydrogenated palm kernel oil suppositories
Study Arms  ICMJE
  • Placebo Comparator: Placebo suppository
    Hydrogenated palm kernel oil suppositories
    Intervention: Drug: Placebo suppository
  • Active Comparator: Anucort-HC, 25 Mg Rectal Suppository
    Hydrocortisone Acetate suppositories
    Intervention: Drug: Anucort-HC, 25 Mg Rectal Suppository
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01913158
Other Study ID Numbers  ICMJE PRG-NY-13-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party G & W Laboratories Inc.
Study Sponsor  ICMJE G & W Laboratories Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Allan G Coates, DO Gastro Associates of Western Michigan
PRS Account G & W Laboratories Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP