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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Hydrocortisone acetate suppositories
Hydrogenated palm kernel oil suppositories
Clinical Research Associates
Huntsville, Alabama, United States
IC Research
Sanford, Florida, United States
Gastro Associates of Western Michigan
Wyoming, Michigan, United States
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.
Time frame: Up to 18 days
Improvement in the Severity Score of Pain
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)
Time frame: Up To 18 days
Improvement in the Severity Score of Itching
Improvement in the Severity Score of Itching from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
Time frame: Up to 18 days
Improvement in the Severity Score of Throbbing
Improvement in the Severity Score of Throbbing to from baseline to Visit 3/Day 8 and Visit 4/Day 15 (End of Treatment)
Time frame: Up to 18 days
Improvement in the Investigator Assessment
Improvement in the Investigator Assessment
Time frame: Up to 18 days
Improvement in the Subject Global Assessment
Improvement in the Subject Global Assessment
Time frame: Up to 18 days
Improvement in Severity of Bleeding
Improvement in the severity of Bleeding from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
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Time frame: Up To 18 days