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NCT01355874 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
A Phase 3 study, sponsored by Ventrus Biosciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 403
- Enrollment target
NCT01355874: Clinical Trial Phase 3 study, sponsored by Ventrus Biosciences.
NCT01355874 is a Phase 3 study that was terminated before completion, run by Ventrus Biosciences. The registered enrollment target is 403 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01355874, a Phase 3 study, was terminated before completion, sponsored by Ventrus Biosciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 403 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the effect of iferanserin ointment on cessation of bleeding when administered intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal hemorrhoids. Methodology: Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group, placebo-controlled part of the study. Extension: Multicenter, open-label part of the study. Study Treatment Duration: Double-Blind: 28 days (14-day treatment period and a 14-day follow-up period). Extension: 12 months (open-label part of the study in which there will be a scheduled visit every three months. Subjects who have recurrence(s) of their symptomatic internal hemorrhoids will be treated with open-label iferanserin for 7 days followed by a 21-day follow-up period). Criteria for Evaluation: Primary Endpoint: The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the remainder of the treatment period (through Day 14).
Interventions
- DRUG Placebo
- DRUG Iferanserin
- DRUG Iferanserin + Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
Why NCT01355874 stopped before completion
NCT01355874 is an interventional study that assigns participants to a tested intervention. The registered 403 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01355874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01355874 about?
NCT01355874 is a clinical study titled "Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids". Primary Objective: To evaluate the effect of iferanserin ointment on cessation of bleeding when administered intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal hemorrhoids. Methodology: Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group...
What is the current status of trial NCT01355874?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 403 participants. The study started on 2011-07. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01355874?
The interventions under investigation include: Placebo (DRUG), Iferanserin (DRUG), Iferanserin + Placebo (DRUG).
Who is sponsoring clinical trial NCT01355874?
This trial is sponsored by Ventrus Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01355874's enrollment target sits among peer trials
403 917th of 2000 higher than 1,082 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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