Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
Public ClinicalTrials.gov record NCT01355874. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Intra-Anal Application of Iferanserin (10 mg) as a 0.5% Ointment in Subjects With Symptomatic Internal Hemorrhoids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01355874
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 403 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2011 (Type not available)
- Primary completion
- Jun 2012 (Actual)
- Completion
- Jun 2012 (Actual)
- Last update posted
- Jan 28, 2014
2011 – 2012
United States locations
- U.S. sites
- 77
- U.S. states
- 24
- U.S. cities
- 71
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health | Dothan | Alabama | — | — |
| Clinical Research Associates | Huntsville | Alabama | — | — |
| Comprehensive Health Services | Phoenix | Arizona | — | — |
| Adobe | Tucson | Arizona | — | — |
| Desert Sun Clin Res | Tucson | Arizona | — | — |
| AR Gastro | Sherwood | Arkansas | — | — |
| ACRI | Anaheim | California | — | — |
| Providence Clin Res | Burbank | California | — | — |
| Med Center | Carmichael | California | — | — |
| South Orange County Surgical Group | Laguna Hills | California | — | — |
| Torrence C. R. | Lomita | California | — | — |
| Premiere Clin Res | Long Beach | California | — | — |
| Facey Med Foundation | Mission Hills | California | — | — |
| Futura Research | Montebello | California | — | — |
| Community Clin Trials | Orange | California | — | — |
| Del Carmen Med Center | Reseda | California | — | — |
| MARG | San Diego | California | — | — |
| Med Center for Clinical Research | San Diego | California | — | — |
| Westlake Res | Westlake Village | California | — | — |
| Colorado Research | Salida | Colorado | — | — |
| Innovative | Clearwater | Florida | — | — |
| Avail Clin Res | DeLand | Florida | — | — |
| Eastern | Hilieah | Florida | — | — |
| Center for GI Disorders | Hollywood | Florida | — | — |
| Nature Coast Clin Res | Inverness | Florida | — | — |
| Jupiter Research | Jupiter | Florida | — | — |
| Aplusresearch | Miami | Florida | — | — |
| Kendall | Miami | Florida | — | — |
| MRA | Miami | Florida | — | — |
| Advanced Gastro Assoc | Palm Harbor | Florida | — | — |
| ICR | Sanford | Florida | — | — |
| Cleveland Clinic Florida | Weston | Florida | — | — |
| Southeast REgional Research Group | Columbus | Georgia | — | — |
| Tri County | Hartwell | Georgia | — | — |
| Southeast Regional Research Group | Savannah | Georgia | — | — |
| Pinnacle Med Inst | Overland | Kansas | — | — |
| Kentucy med Center | Lexington | Kentucky | — | — |
| Praetorian Pharmaceutical Res | Marrerro | Louisiana | — | — |
| Clinical Trials Mgmt | Metarie | Louisiana | — | — |
| Delta Research | Monroe | Louisiana | — | — |
| Women Under Study | New Orleans | Louisiana | — | — |
| Capital Digestive | Chevy Chase | Maryland | — | — |
| Meritus Center for Clin Res | Hagerstown | Maryland | — | — |
| Mid Atlantic Res Center | Hollywood | Maryland | — | — |
| Saginaw Med Res | Saginaw | Michigan | — | — |
| Gastro Assoc Western Michigan | Wyoming | Michigan | — | — |
| Gastrointestinal Associates | Jackson | Mississippi | — | — |
| Midwest Center for Clin Res | Lee's Summitt | Missouri | — | — |
| Center for Digestive & Liver Diseases | Mexico | Missouri | — | — |
| Clin Res Nevada | Las Vegas | Nevada | — | — |
| S. Jersey Gastro | Marlton | New Jersey | — | — |
| Long Island GI Group | Great Neck | New York | — | — |
| MRA NY | New York | New York | — | — |
| Ashville Gastro | Asheville | North Carolina | — | — |
| Carolinas Res Ass | Davidson | North Carolina | — | — |
| Vital | Greenboro | North Carolina | — | — |
| Carolinas Research | Harrisburg | North Carolina | — | — |
| Wake Res | Raleigh | North Carolina | — | — |
| Trial Management Associates | Wilmington | North Carolina | — | — |
| Hightop Med Res | Cincinnati | Ohio | — | — |
| Dayton Gastro | Dayton | Ohio | — | — |
| Great Lakes Gastro | Mentor | Ohio | — | — |
| Central Sooner | Norman | Oklahoma | — | — |
| Clinsearch | Chattanooga | Tennessee | — | — |
| Memphis Gastro | Germantown | Tennessee | — | — |
| Assoc of Gastro | Hermitage | Tennessee | — | — |
| Dial Research | Nashville | Tennessee | — | — |
| First Clinic | Nashville | Tennessee | — | — |
| Texas Health Research | Fort Worth | Texas | — | — |
| Amcare Research | Houston | Texas | — | — |
| Houston Gastro | Houston | Texas | — | — |
| Permian | Odessa | Texas | — | — |
| Pioneer Research | Sugarland | Texas | — | — |
| ARI | Ogden | Utah | — | — |
| ARI | Sandy City | Utah | — | — |
| New River Valley Res | Christianburg | Virginia | — | — |
| Blue Ridge Medical Center | Lyncburg | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01355874, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 28, 2014 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01355874 live on ClinicalTrials.gov.