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.