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

NCT01913158 | Completed Phase 2

• 1 other identifier: PRG-NY-13-002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Internal Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Bleeding Cessation

  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.

  Up to 18 days

Secondary Outcomes (6)

• Improvement in the Severity Score of Pain

  Up To 18 days

• Improvement in the Severity Score of Itching

  Up to 18 days

• Improvement in the Severity Score of Throbbing

  Up to 18 days

• Improvement in the Investigator Assessment

  Up to 18 days

• Improvement in the Subject Global Assessment

  Up to 18 days

Study Arms (2)

Placebo suppository

PLACEBO COMPARATOR

Hydrogenated palm kernel oil suppositories

Drug: Placebo suppository

Anucort-HC, 25 Mg Rectal Suppository

ACTIVE COMPARATOR

Hydrocortisone Acetate suppositories

Drug: Anucort-HC, 25 Mg Rectal Suppository

Interventions

Anucort-HC, 25 Mg Rectal Suppository DRUG

Hydrocortisone acetate suppositories

Also known as: Hydrocortisone acetate suppositories

Anucort-HC, 25 Mg Rectal Suppository

Placebo suppository DRUG

Hydrogenated palm kernel oil suppositories

Also known as: Hydrogenated palm kernel oil suppositories

Placebo suppository

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a diagnosis of symptomatic internal hemorrhoids will be selected to participate in the study.
• 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.
• 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.
• Subject may also have one or more other symptoms: pain, itching or throbbing.
• 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).

You may not qualify if:

• History of permanent full-thickness rectal prolapse.
• Current anal fissures and/or infective anal pathology.
• Previous history of surgery for anorectal disease (within 1 year) or any other anorectal procedures
• Subjects who are mentally incapacitated such that informed consent cannot be obtained.
• Clinically significant co-morbid condition.
• Diagnosis of Inflammatory Bowel Disease (IBD).
• Evidence or history of fecal incontinence.
• Clinically significant Laboratory values for hematology and chemistry .
• Subjects who have had oral, transdermal, or injectable steroid therapy within days from Visit 1/Screening.
• 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.
• Clinically significant systemic disease.
• Pelvic radiation in the past or present.
• Use of any venotropic medications within 7 days from Visit 2/Day 1.
• Use of any anti-coagulant medications within 10 days from Visit 2/Day 1.
• Use of topical/anorectal corticosteroids for hemorrhoidal therapy within 7 days from Visit 2/Day 1.

Sponsors & Collaborators

• G & W Laboratories Inc.: lead

Study Sites (3)

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

IC Research

Sanford, Florida, 32771, United States

Location

Gastro Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

MeSH Terms

Interventions

Hydrocortisone; Suppositories

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Allan G Coates, DO

  Gastro Associates of Western Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: July 31, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 3, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)