Status:
COMPLETED
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
Lead Sponsor:
Nivagen Pharmaceuticals Inc.
Conditions:
Internal Hemorrhoids
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo suppositories in the tre...
Detailed Description
STUDY DESIGN: 25 mg hydrocortisone suppositories administered twice daily compared to a vehicle placebo in approximately 100 subjects with symptomatic internal hemorrhoids. Subjects will be randomize...
Eligibility Criteria
Inclusion
- internal hemorrhoids.
- hemorrhoidal bleeding.
- male or female aged 18 years and older.
- willing to forego the use of non-prescription (OTC) and prescription medication or procedures for the treatment of hemorrhoidal disease and/or pain for the duration of the study.
- agree to not change their diet during the study.
Exclusion
- external hemorrhoids.
- using other OTC or prescription medications for treatment of hemorrhoidal disease and/or pain.
- pregnant or nursing female.
- received systemic glucocorticoids within the last 2 months prior to starting study.
- participated in an investigational drug study within 30 days prior to baseline.
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2021
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03335774
Start Date
February 12 2019
End Date
March 5 2021
Last Update
September 13 2022
Active Locations (2)
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1
Clinical Research
Charlotte, North Carolina, United States, 28217
2
Clinical Research
Navi Mumbai, Maharashtra, India, 400701