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

November 6, 2019

Overview

This clinical trial studies the safety and efficacy of Hydrocortisone Acetate Suppositories in the treatment of symptomatic internal hemorrhoids. Patients who meet the inclusion criteria will receive either 25 mg of the suppository or a placebo.

 

Study Information

This is a randomized double-blind study with a treatment arm and a placebo arm. The treatment arm will receive 25 mg of Hydrocortisone Acetate Suppositories inserted into the anal canal twice daily for 2 weeks. The placebo arm will receive a placebo suppository for the same duration and with the same frequency.

 

Inclusion Criteria

 

  • Internal hemorrhoids.
  • Hemorrhoidal bleeding.
  • All sexes
  • Ages 18+
  • 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 over-the-counter 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.

 

Location

Charlotte, North Carolina, United States, 28217

 

Sponsors/Collaborators

Nivagen Pharmaceuticals Inc.

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