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

Phase 2

Completed

• Conditions: Internal Hemorrhoids
• Interventions: Drug: Placebo suppository; Drug: Anucort-HC, 25 Mg Rectal Suppository

• Registration Number: NCT01913158
• Lead Sponsor: G & W Laboratories Inc.

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 Timeline

• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Study Start: 2013-10
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Disposition First Submitted: 2016-09-09
• Status Verified: 2016-11
• Disposition First Submitted QC: 2016-11-02
• Last Update Submitted: 2016-11-02
• Disposition First Posted: 2016-11-03
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo suppository	Placebo suppository	Hydrogenated palm kernel oil suppositories
Anucort-HC, 25 Mg Rectal Suppository	Anucort-HC, 25 Mg Rectal Suppository	Hydrocortisone Acetate suppositories

Primary Outcome Measures

Name	Time	Method
Bleeding Cessation	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in the Severity Score of Pain	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	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	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	Up to 18 days	Improvement in the Investigator Assessment
Improvement in the Subject Global Assessment	Up to 18 days	Improvement in the Subject Global Assessment
Improvement in Severity of Bleeding	Up To 18 days	Improvement in the severity of Bleeding from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)

Trial Locations

Locations (3)

Clinical Research Associates; 🇺🇸 Huntsville, Alabama, United States

IC Research; 🇺🇸 Sanford, Florida, United States

Gastro Associates of Western Michigan; 🇺🇸 Wyoming, Michigan, United States