Internal Hemorrhoids Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01355874 -
Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
|
Phase 3 | |
Completed |
NCT01533363 -
Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy
|
Phase 3 | |
Completed |
NCT03335774 -
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
|
Phase 2 |