MedTrace Logo

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

NCT03335774 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2022-09-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Internal Hemorrhoids

Interventions

DRUG

Hydrocortisone Acetate Suppository, 25 mg (Nivagen)

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

DRUG

Placebo (Vehicle) Suppository (Nivagen)

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

Sponsors & Collaborators

  • Nivagen Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Anand Shukla, MS, MBA, · Nivagen Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2021-03-05
Completion
2021-03-05
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03335774 on ClinicalTrials.gov