Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

NCT03335774 · View on ClinicalTrials.gov ↗

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

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03335774

The ClinicalTrials.gov registry entry for NCT03335774 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03335774 reports 2 study locations spanning 2 distinct geographic areas — top geographies include North Carolina, Maharashtra. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03335774?

This trial is sponsored by Nivagen Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial