Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Ventrus Biosciences. The registered enrollment target is 403 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01355874
The ClinicalTrials.gov registry entry for NCT01355874 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 403 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ventrus Biosciences, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01355874 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.