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NCT03335774 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Internal Hemorrhoids, sponsored by Nivagen Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
103
Enrollment target
2
Study locations

NCT03335774 is a Phase 2 study of Internal Hemorrhoids that has completed, run by Nivagen Pharmaceuticals. The registered enrollment target is 103 participants. The trial reports 2 study locations across 2 states.

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The verdict

NCT03335774, a Phase 2 study of Internal Hemorrhoids, has completed, sponsored by Nivagen Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
103 participants
Enrollment target
2
Study locations

Study 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 Studied

Interventions

  • DRUG Hydrocortisone Acetate Suppository, 25 mg (Nivagen)
  • DRUG Placebo (Vehicle) Suppository (Nivagen)

Study Locations (2)

North Carolina

  • Clinical Research - Charlotte

Maharashtra

  • Clinical Research - Navi Mumbai

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2019-02-12
Est. Completion 2021-03-05
Phase Phase 2

Sponsor

Nivagen Pharmaceuticals

1 total trials

What the Registry Record Tells You About NCT03335774

The ClinicalTrials.gov registry entry for NCT03335774 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nivagen Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Internal Hemorrhoids appearing as the primary indexed condition, and to 2 interventions - of which Hydrocortisone Acetate Suppository, 25 mg (Nivagen) is the first listed.

NCT03335774 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Maharashtra.

Frequently Asked Questions

What is clinical trial NCT03335774 about?

NCT03335774 is a clinical study titled "Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids". 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.

What is the current status of trial NCT03335774?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2019-02-12. Estimated completion is 2021-03-05.

What conditions does trial NCT03335774 study?

This clinical trial studies the following conditions: Internal Hemorrhoids.

What interventions are being tested in trial NCT03335774?

The interventions under investigation include: Hydrocortisone Acetate Suppository, 25 mg (Nivagen) (DRUG), Placebo (Vehicle) Suppository (Nivagen) (DRUG).

Who is sponsoring clinical trial NCT03335774?

This trial is sponsored by Nivagen Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03335774 being conducted?

This trial has 2 study locations across North Carolina, Maharashtra. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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