Overview

Study of the Safety and Efficacy of Hydrocortisone Acetate Suppositories, 25 mg in the Treatment of Symptomatic Internal Hemorrhoids

Status:
Completed
Trial end date:
2021-03-05
Target enrollment:
0
Participant gender:
All
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 treatment of symptomatic internal hemorrhoids.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nivagen Pharmaceuticals Inc.
Treatments:
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.