CompletedPhase 2

Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids

United States, India103 participantsStarted 2019-02-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Reduction in Swelling

Timeframe: Day 15

Reduction in Itching Severity

Timeframe: Day 15

Trial details

NCT IDNCT03335774

SponsorNivagen Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-05

Results submitted2022-04-27

View on ClinicalTrials.gov More Internal Hemorrhoids trials