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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: Completed Phase 2 study of Internal Hemorrhoids, sponsored by Nivagen Pharmaceuticals.
NCT03335774 is a Phase 2 study of Internal Hemorrhoids that has completed, run by Nivagen Pharmaceuticals. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Reduction in the swelling of internal hemorrhoid was measured by anoscopy. Visual assessment of hemorrhoids was performed at end of treatment. Video of the procedure will be recorded for blinded central reading and assessment. Swelling was graded on a scale from "0 - None" to "4 - Very Severe". Numeric grades and their changes from baseline are summarized descriptively by visit and treatment group. Changes from baseline will be compared between the treatment groups. Mean difference between the
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
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2021-03-05 |
| Phase | Phase 2 |
What the finished NCT03335774 record still lists
NCT03335774 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
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 a single indexed study location in 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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Where NCT03335774's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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