CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
Hydrocortisone Acetate Suppository, 25 mg (Nivagen) +1 moredrug
Likely dose
Hydrocortisone Acetate Suppository, 25 mg (Nivagen)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03335774
NCT03335774Phase 2Completed

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in the Treatment of Symptomatic Internal Hemorrhoids.

Nivagen Pharmaceuticals Inc.·interventional·Posted Nov 8, 2017·Updated Sep 13, 2022

In Brief

A Phase 2 clinical trial evaluating Hydrocortisone Acetate Suppository, 25 mg (Nivagen) and Placebo (Vehicle) Suppository (Nivagen) for Internal Hemorrhoids. Completed, enrolled 103 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 8, 2017
Enrollment StartFeb 12, 2019
Primary CompletionMar 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.7 years ago

Interventions

Hydrocortisone Acetate Suppository, 25 mg (Nivagen)drug

One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).

Placebo (Vehicle) Suppository (Nivagen)drug

One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).